Medical Affairs Lead Jobs

Who we are Artefact is a global data and AI consulting firm. We help organisations turn data and AI into measurable business impact across the value chain, from strategy and operating model to data platforms, AI products and marketing. More than 2,500 consultants, data scientists and engineers work for over 1,000 clients worldwide, including Samsung, L’Oréal, Orange and Sanofi. In Switzerland, our team of around 50 people works from Zurich and Lausanne with Swiss and international companies. Our work covers AI strategy and governance, data transformation and AI use cases that run in production. What you will be doing: Key responsibilities We are looking for a Partner to scale Artefact’s Pharma & Life Sciences practice in Switzerland. Many global pharma, biotech and medtech companies run their headquarters, R&D, manufacturing or commercial functions from Switzerland. We already work with life sciences clients here and now want to make this practice one of the pillars of our Swiss business. This is an origination role: most of your time goes into winning new clients and expanding existing relationships. You will be based in Zurich and work with clients across Basel, Zurich and Romandie. Your role will encompass: Scaling the Swiss Life Sciences practice: its offer, its client base and its team, in coordination with Artefact’s global healthcare and life sciences teams. Growing existing client relationships and winning new clients, so that the practice moves from first references to a broad portfolio. Leading senior client stakeholders (CDO/CDAO, CIO, heads of Commercial Excellence, Medical Affairs, R&D Operations, Manufacturing & Quality) through data and AI transformation. Overseeing project delivery and quality assurance on our life sciences engagements, and giving strategic support to ongoing client programmes. Sparring with the Swiss Managing Partner on practice strategy and investment. Among your responsibilities as Partner, you will: Build the prac

Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is dedicated to delivering prescription-grade therapy with an outstanding user experience. We have pioneered the world’s first drug-free wearable therapy, clinically proven to alleviate symptoms in adults with drug-resistant Restless Legs Syndrome (RLS). Join us in transforming healthcare, improving lives, and driving meaningful change through innovative medical technology. We are seeking an experienced and highly organized Manager, Regulatory Affairs to lead and execute regulatory activities supporting the development, registration, commercialization, and post-market compliance of Noctrix Health’s medical devices. This role will help ensure regulatory strategies and deliverables are executed accurately, compliantly, and on schedule throughout the product lifecycle. The Manager, Regulatory Affairs will work closely with Clinical Affairs, Quality, Engineering, Operations, Marketing, and external regulatory partners to provide regulatory guidance, manage submissions, assess product changes, maintain global registrations, and support post-market regulatory activities. The ideal candidate combines strong medical device regulatory expertise with excellent project management skills and the ability to independently drive complex regulatory initiatives across multiple functions. This position reports to the Senior Vice President, Clinical & Regulatory Affairs . This is a full-time, hybrid position that is located at our Pleasanton headquarters. Responsibilities: Provide regulatory guidance to cross-functional teams supporting new product development, design changes, risk management, commercialization, and product lifecycle activities Perform and maintain regulatory assessments for product modifications, soft

Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is dedicated to delivering prescription-grade therapy with an outstanding user experience. We have pioneered the world’s first drug-free wearable therapy, clinically proven to alleviate symptoms in adults with drug-resistant Restless Legs Syndrome (RLS). Join us in transforming healthcare, improving lives, and driving meaningful change through innovative medical technology. We are seeking an experienced and strategic Director, Clinical Affairs to lead the planning, execution, and oversight of clinical studies supporting the development, regulatory approval, reimbursement, and commercialization of Noctrix Health’s medical devices. This leader will be accountable for the successful delivery of clinical programs, ensuring studies are executed efficiently, compliantly, on schedule, and within budget while generating high-quality clinical evidence that supports regulatory and business objectives. The Director, Clinical Affairs will serve as a key cross-functional leader and liaison among Clinical Affairs, Clinical Research, Regulatory Affairs, Quality, Product Development, and external partners. This individual will provide leadership across clinical operations, including sponsor oversight, site management, CRO and vendor management, clinical data quality, study execution, and evidence generation. This position reports to the Senior Vice President, Clinical & Regulatory Affairs . This is a full-time, hybrid position that is located at our Pleasanton headquarters. Responsibilities: Lead the planning, execution, and oversight of medical device clinical studies from study start-up through close-out Contribute to clinical development strategies supporting product development, regulatory submissions, reimburse

About Us At BGBx , we're driven by a simple idea: breakthrough thinking creates breakthrough impact. As an independent commercial solutions partner to pharmaceutical and life science companies, we bring together strategists, scientists, communicators, creatives, technologists, and data experts to tackle some of healthcare's most important challenges. Our teams work across consulting and communications to help clients shape strategy, launch innovations, engage stakeholders, and drive meaningful results throughout the product lifecycle. The work is complex, fast-moving, and deeply connected to improving lives, creating opportunities for curious minds to make a real difference every day. If you're energized by collaboration, inspired by innovation, and motivated by work that matters, you'll find a place to grow, contribute, and make a meaningful impact at BGBx. Medical Director Position Overview The Medical Director is the Medical strategy/content lead on his/her brand(s). They must have a proven record of independently executing the responsibilities and successfully demonstrating the competencies outlined below, and must demonstrate the ability to successfully onboard , train, and mentor others in the Associate Medical Director (AMD), Senior Medical Writer (SMW) and/or Medical Writer (MW) roles. Please see required experience below. Key Responsibilities: Content Development & Execution: Manages the scope of existing work and assumes primary responsibility for overseeing translation and execution of BGB standards, client expectations, and brand strategy Provides strategic guidance to team/brand from kick-off through execution (reviewing for messaging and style) Reviews deliverables and ensures that BGB standards, client expectations, and brand strategy are met; assumes lead role in strategy-heavy projects Assumes accountabilit

About Us At BGBx , we're driven by a simple idea: breakthrough thinking creates breakthrough impact. As an independent commercial solutions partner to pharmaceutical and life science companies, we bring together strategists, scientists, communicators, creatives, technologists, and data experts to tackle some of healthcare's most important challenges. Our teams work across consulting and communications to help clients shape strategy, launch innovations, engage stakeholders, and drive meaningful results throughout the product lifecycle. The work is complex, fast-moving, and deeply connected to improving lives, creating opportunities for curious minds to make a real difference every day. If you're energized by collaboration, inspired by innovation, and motivated by work that matters, you'll find a place to grow, contribute, and make a meaningful impact at BGBx. Position Overview The Associate Medical Director is the Medical Brand lead on their brand(s) and is responsible for the development and strategic alignment of medical content with brand objectives. The Associate Medical Director is the primary medical contact for the client and is responsible for the scientific accuracy, quality, and timeliness of all ongoing projects for the brand. The Associate Medical Director acts as mentor for Medical Writers/Senior Medial Writers and may have managerial responsibilities (direct reports). Responsibilities Content Development & Execution: Is accountable for all assigned projects; assumes greater volume than SMW or MW Oversees and creates content for a brand, including reviewing content developed by SMW/MW for scientific accuracy and alignment to strategy/client objectives before senior team review Writes and annotates content as appropriate Ensures that all projects, including those led by direct reports, meet external and internal timelines and agreed to deadlines Keeps track of all ongoing projects and learns how to assess

About Us At BGBx , we're driven by a simple idea: breakthrough thinking creates breakthrough impact. As an independent commercial solutions partner to pharmaceutical and life science companies, we bring together strategists, scientists, communicators, creatives, technologists, and data experts to tackle some of healthcare's most important challenges. Our teams work across consulting and communications to help clients shape strategy, launch innovations, engage stakeholders, and drive meaningful results throughout the product lifecycle. The work is complex, fast-moving, and deeply connected to improving lives, creating opportunities for curious minds to make a real difference every day. If you're energized by collaboration, inspired by innovation, and motivated by work that matters, you'll find a place to grow, contribute, and make a meaningful impact at BGBx. Position Overview The Senior Medical Director, Medical Strategy & Scientific Affairs is responsible for leading the strategic direction and hands-on creation of high-quality medical and scientific content across multiple therapeutic areas. This role holds overall accountability for the medical and scientific integrity of both ongoing medical education programs and new business proposals. The Senior Medical Director will work on high-profile and strategic projects, with significant visibility both within the company and with clients. This position involves frequent interactions with clients and internal teams, ensuring alignment and effective communication. The Senior Medical Director will manage a team that includes Associate Medical Directors, Medical Writers, and Medical Interns, while also serving as a key liaison across various departments. The role requires the development of strong professional relationships with key customers and active participation in the creation of new service offerings that address the evolving needs of Evolution’s pharmaceutica

JOB DESCRIPTION: About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to: Career development with an international company where you can grow the career you dream of. A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position is based at our Mississauga office within the Medical division and requires on‑site presence four days per week, with the option to work remotely one day. What You’ll Do Prepare robust regulatory applications to achieve departmental and organizational objectives. Create, review and approve engineering changes. Act as a team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed. Review and evaluate communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards to various local affiliates. Maintain pertinent Canadian medical device regulations to ensure submission requirements are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and

About Tr1X Tr1X is a clinical-stage biotechnology company developing engineered Tr1 cell therapies to restore immune balance in autoimmune and inflammatory diseases. Leveraging the unique biology of Tr1 cells, the company is advancing a pipeline of off-the-shelf allogeneic and in vivo CAR-Tr1 therapies designed to deliver targeted immunoregulation and address diseases driven by immune dysfunction, including transplant-related complications. Founded by pioneers in the discovery of Tr1 cells, Tr1X, Inc. is focused on developing durable, potentially curative therapies for conditions with high unmet need. For more information, visit www.tr1x.bio. Position Summary The Director, Medical and Regulatory Writing reports to the Vice President, Head of Regulatory Affairs and provides strategic planning, development, review, and delivery of high-quality medical, clinical, and regulatory documentation supporting Tr1X clinical programs. The role is responsible for establishing and executing medical writing strategies across clinical development programs, ensuring the timely preparation of scientifically accurate, regulatory-compliant documentation. The Director drives document quality and operational excellence and collaborates with senior leaders across Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Translational Medicine, CMC/Technical Operations, and other functions. The position plays a critical role in supporting regulatory milestones and submissions throughout the product lifecycle, while ensuring alignment with applicable regulatory requirements, scientific standards, and corporate objectives. Key Responsibilities Partner with Regulatory to develop and implement the medical writing strategy in alignment with corporate objectives, clinical development plans, regulatory strategies, and program goals. Author (writes & edits) high-quality documents across all program areas as needed such as clinical study protocols, protocol ame

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This Regulatory Affairs Manager – APAC position will work on-site at our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing produc

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging cathe

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and s

Responsibilities Set and lead the country/regional patient advocacy strategy, aligned with business, policy and reputation priorities. Build trusted, long-term partnerships with patient, professional, community and trade organizations; serve as the senior point of contact for priority relationships. Bring patient insights and the patient voice into policy, research, development, medical and commercial decision-making across the medicine lifecycle. Create coalitions and collaborative platforms that advance shared policy priorities, improve access to medicines and vaccines, and strengthen patient education. Advise senior leaders on emerging patient, policy and reputation opportunities and risks, with clear short-, medium- and long-term action plans. Partner across Policy and Public Affairs, Communications, Digital, WRDM (Worldwide Research, Development and Medical), GPD (Global Product Development) and business teams to scale patient-engagement standards, tools and best practices. Represent Pfizer in relevant external forums and advisory bodies and lead high-impact advocacy engagements and events. Core Competencies Strategic leadership and sound judgment Patient organization management and trusted relationship building Influence, collaboration and coalition building Clear, credible executive communication Execution, accountability and agility Key Relationships Internal: Patient Advocacy leadership; Policy and Public Affairs; Communications; Commercial; Medical; Regulatory Affairs; Digital; Research and Development; and other enterprise stakeholders. External: Patient and professional advocacy organizations, community and provider groups, trade associations, policy thought leaders and other relevant partners. Qualifications Bachelor’s degree requi

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life JOB TITLE: シニア薬事スペシャリスト DEPARTMENT: 品質保証・薬事（薬事Cardiovascular/DIBポートフォリオ） REPORTING TO: 薬事マネジャー ********************************************************************************************** Main Mission of Job “Being a “bridge” to deliver “meaningful” medical device to Japanese patients” 日本の患者さんに価値のある医療機器を届ける架け橋となる Main Responsibilities 血管内治療機器に関連する薬事業務に従事いただきます。 新製品のタイムリーな国内導入に向け、その製品特性、開発計画、市場およびビジネス上のニーズ、上市戦略を理解し、米国本社およびマーケティング部門と協力して、薬事承認および保険に関する申請戦略および作業計画を立案する。 薬事申請戦略および作業計画に基づき、米国本社および国内関連部門の協力を得て必要な情報を収集し、行政当局との相談を行いながら、質の高い申請書を効率よく作成して審査当局に提出し、承認取得する。 保険申請戦略に基づき、必要な申請書を作成し当局に提出する。区分C1またはC2申請を行う場合は、マーケティング部門、保険担当部門と協力して、国内外のエビデンスの収集、保険適用申請書の作成と提出、説明資料の作成、関連学会や行政当局との折衝を行う。 製品の流通に際し、モデル情報の登録や帳票類の整備等、付帯する薬事関連業務を行う。 米国本社との良好な信頼関係とコミュニケーションを維持して、必要な情報をタイムリーかつ正確に取得し、薬事行政上の必要な判断や措置を遅滞なく講じる。 国内薬事関連法令やグローバルな薬事行政の動向、担当する製品群および関連治療についての最新の情報・知識を収集する。 業界活動を通じ、品目の基準作成、薬事関連、保険関連などにおいて、業界側の考えを行政に提案する。 Must Haves 学士（４年制理系大学卒）以上又はそれに相当する学位 医療機器又は医薬品の薬事申請業務（クラスⅣの医療機器の薬事申請経験があれば尚可） 米国本社との情報交換及び技術英語読解に必要な英語能力

Work Flexibility: Remote Staff Regulatory Affairs Specialist, Mako and Enabling Technologies (Remote) Join Stryker’s Ortho Tech Business and support a portfolio that spans robotics, navigation, imaging, software, and capital equipment technologies. In this role, you will provide regulatory leadership throughout the product lifecycle, partnering with cross-functional teams to support global product development, regulatory submissions, market access, and ongoing regulatory compliance across U.S. and international markets. Work Flexibility: This is a remote position, with a preference for candidates located in the U.S. Eastern Time Zone What You Will Do Develop and execute global regulatory strategies for new products, product changes, and lifecycle management activities. Participate in product development teams to ensure U.S., European, and international regulatory requirements are incorporated throughout all development phases. Evaluate product classifications, regulatory pathways, and jurisdictional requirements for medical devices and related technologies. Author and submit regulatory filings, including FDA submissions, international registrations, and supporting documentation required for product approvals. Review quality, preclinical, and clinical documentation to ensure submission readiness and regulatory compliance. Partner with global regulatory affiliates to support registrations, market expansions, and post-market regulatory activities. Lead interactions with regulatory authorities and notified bodies, including preparation of responses, submissions, and agency communications. Review product labeling, marketing materials, and product claims for compliance with applicable regulatory requirements and mentor junior regulatory team members on regulatory

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Summary: This position supports Baxter's mission to save and sustain lives through advancing and protecting Baxter’s business interests and creating a favorable policy and market access environment to expand patient access to our products, therapies and solutions, to drive commercial opportunities and deliver value to Baxter. Working closely with country leadership teams, commercial, medical, regulatory, and global stakeholders, this involves: - Strategic external engagement with government stakeholders, payers, patients, professional and trade associations to shape legislation, policy adoption and healthcare priorities. - Building coalitions to advance and protect patient access to our products and services. - Payer engagement and evidence-based value demonstration to support reimbursement and funding decisions.