Regulatory Affairs Manager Jobs

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description As the primary Public Affairs liaison to the R&D organization, the V ice P resident will develop and execute an integrated internal and external communications strategy that advances enterprise priorities, strengthens trust in our science, and enables business readiness for key pipeline and regulatory events. This leader will provide senior counsel to R&D and enterprise leaders on reputation and risk, set the operating model and governance for R&D communications globally, and build a high-performing team with deep scientific, regulatory, and issues-management expert

About the team OpenAI’s mission is to ensure that artificial general intelligence benefits all of humanity. OpenAI for Government (OAI4G) helps public-sector institutions understand, adopt, and deploy highly capable AI products in support of their missions. The team brings together Sales, Solutions, Partnerships, Technical Success, Legal, Security, Policy, Global Affairs, and other cross-functional partners to help governments use AI responsibly and effectively. As part of OAI4G’s International Public Sector team, you will help public institutions in Australia and New Zealand (ANZ) and APAC translate frontier AI into secure, compliant, mission-aligned outcomes. We work across varied procurement, regulatory, security, sovereignty, and commercial environments, while maintaining a consistent commitment to safety, reliability, and public benefit. About the role We are seeking a senior Account Director (AD) to lead OpenAI’s public-sector work across ANZ, with a wider remit to develop selected priority opportunities across APAC. ANZ will be the centre of gravity for the role: you will build trusted relationships with government leaders, develop and execute account strategies, create and close complex opportunities, and help customers move from initial interest to successful adoption. This is a full-cycle, highly cross-functional sales role that combines technical understanding, strategic vision, partnership management, and value-driven execution. You will work with senior government, operational, technical, procurement, policy, and security stakeholders to identify high-impact AI use cases and translate them into credible commercial and deployment pathways across the OpenAI Platform API and Codex and ChatGPT Enterprise. You will also be an accountable customer leader after signature, working alongside specialist delivery and technical teams to keep customer outcomes, milestones, adoption, risks, and executive alignment on track. The role requires excellent judgement, exec

About the Team OpenAI's Legal team plays a crucial role in furthering OpenAI's mission by tackling innovative, fundamental legal issues in AI. If you're passionate about doing significant and unique work as a technology lawyer, this team is for you. The team comprises legal professionals from diverse fields, including technology, privacy, IP, corporate, cybersecurity, employment, tax, regulatory, and litigation. About the Role We’re growing our world-class Legal team and seek an experienced counsel to lead our global hardware IP portfolio initiatives, including patent, trademark and other intellectual property matters related to our business. This role is highly cross-functional across OpenAI, including work across our Legal, Communications, Global Affairs, Product, Research and Executive teams. This role is based in San Francisco, CA. We use a hybrid work model of 3 days in the office per week and offer relocation assistance to new employees. In this role, you will: Own global hardware IP initiatives, including setting and executing on the strategic direction and management of our hardware IP portfolio. Create scalable processes internally and externally with outside counsel to build, maintain and protect our hardware IP portfolio. Developing and maintaining internal hardware IP policies and programs. Engaging externally on hardware IP policy issues. Advising on strategic hardware IP deals. Advising on hardware IP issues, ranging from patent, trademark, trade secret to open source. Developing and building internal AI expertise, processes and tools to facilitate legal team work. Experience advising on complex technology transactions and inbound technology licensing. You might thrive in this role if you: Have at least 10+ years of combined hardware IP experience at innovative technology companies and law firms. Have a JD and license or qualification to practice in CA. Have a strong sense of ownership, are inquisitive and enthusiastic about technology, enjoy being con

Every day, tens of millions of people come to Roblox to explore, create, play, learn, and connect with friends in 3D immersive digital experiences– all created by our global community of developers and creators. At Roblox, we’re building the tools and platform that empower our community to bring any experience that they can imagine to life. Our vision is to reimagine the way people come together, from anywhere in the world, and on any device. We’re on a mission to connect a billion people with optimism and civility, and looking for amazing talent to help us get there. A career at Roblox means you’ll be working to shape the future of human interaction, solving unique technical challenges at scale, and helping to create safer, more civil shared experiences for everyone. Senior Director, Policy Communications Roblox is looking for an experienced communicator to support a wide range of issues, including leading public affairs communications. You will report to the Chief Communications Officer. As a member of the Global Communications and Corporate Affairs team, you will guide the development and implementation of corporate positioning and crisis management on a global scale. You will devise specific communications materials and campaigns to inform and educate our community, opinion leaders, media about the benefits of Roblox products, our company culture/values and our approach to public policy issues of the day. You will follow the regulatory environment that impacts our industry and, as appropriate, work with the policy team to comment on or respond to legislation. You will participate in face-to-face meetings with commentators and other opinion formers, develop print and web-based material supporting these campaigns, and counter misinformation that might interfere with our business and ability to serve our community. This role will ideally be based in either our Washington DC or San Mateo, CA offices (hybrid Tu

Job Title Design Quality Engineer Job Description Job title: Design Quality Engineer You Role: While positioned within the Business Unit MR, reporting to the Segment OEM & Coils DQE Leader, you will support the Quality, Reliability and Safety of Medical Devices though all lifecycle phases of the medical device. You will contribute to achieve quality objectives as they relate to: Customer Experience, Complaint Rate, and First Past Yield. You will work in an independent Quality & Regulatory organization with key stakeholders during various stages of the design, development and maintenance of the medical device. Representing Design Quality during the execution of new development programs and sustaining activities and interfacing with regulatory affairs Independent oversight of product performance as this relates to Product Quality, Safety and Reliability During (early) Development and Lifecycle Maintenance: Participate in establishing the quality and reliability strategy specific to the product(s) in scope. Involved in quality target setting in Project Charter Act as a product quality lead by defining the activities in the Product Quality Plan to meet product quality targets Contribute to the execution and delivery of results specific to product quality: Review reliability plans , review key quality related requirements , ensure a proper transfer of design specifications to manufacturing and supply chain and service, perform assessment on the design/architecture on suitability for the quality criteria, and review key product related deliverables (Reliability Reports, Reliability modelling for predictive analysis, FMEA’s, Change Point Analysis, etc.) Apply and facilitate Design for Quality & Reliability best practices (FMEAs, ro

URGENT HIRING Government Liaison Manager South Kolkata Recruitment Partner: IDEAL CAREER ZONE A reputed Group of Companies near Gariahat, South Kolkata is looking for an experienced Government Liaison Manager. Location: South Kolkata Position: Government Liaison Manager Qualification: Graduate (Preferred) Salary: Best in Industry (Based on Experience) Preferred Age: 45 58 Years Experience: Minimum 5 Years (Preferred) Key Responsibilities Liaise with Central, State & Local Government Departments Obtain approvals, licenses, permissions & statutory compliances Coordinate with Municipal Corporation, Revenue, Land Records, Police, Fire, Pollution Control Board & Electricity Board Monitor government policies and regulatory updates Handle official meetings, documentation & government correspondence Build strong relationships with government authorities while ensuring complete compliance Required Skills Excellent communication & negotiation skills Strong coordination & problem-solving ability Trustworthy, professional & presentable personality Ability to work independently with complete confidentiality Interested candidates can send their updated CV to IDEAL CAREER ZONE. Call/WhatsApp: 9231799122// 8777211016 // 9331205133 #Hiring #GovernmentLiaison #LiaisonManager #GovernmentRelations #Compliance #CorporateJobs #KolkataJobs #SeniorJobs #Administration #RegulatoryAffairs #ImmediateHiring #IdealCareerZone

About the Team OpenAI’s mission is to ensure that general-purpose artificial intelligence benefits all of humanity. Achieving this requires effective engagement with policymakers and the broader communities impacted by AI. Our Global Affairs team builds authentic, collaborative relationships with public officials and the wider AI policymaking community. We work to ensure that insights from policymakers and external stakeholders inform OpenAI’s work and, in collaboration with colleagues across the organization, support the development of thoughtful regulation, industry standards, and the safe and beneficial development of AI. About the Role As the Policy and Partnerships Lead CEE & Baltics, you will develop and lead OpenAI’s public policy and partnerships strategy across Central and Eastern Europe and the Baltics as part of our broader European team. You will determine where OpenAI should engage most deeply, develop differentiated country strategies, and connect national political and policy dynamics with OpenAI’s broader European and global objectives. You will build trusted relationships with governments, regulators, public administrations, civil society, business, research institutions, and other influential stakeholders, while identifying practical, high-impact opportunities to demonstrate how AI can contribute to economic competitiveness, public-sector modernization, education and skills, security, resilience, and broader societal benefit. You will also serve as an important bridge between national capitals and Brussels, surfacing regional intelligence, assessing where national debates may influence Europe-wide outcomes, and translating OpenAI’s European priorities into locally credible strategies and engagement. This is a senior, high-ownership role at the intersection of public policy, government affairs, and partnership building. You will work closely with colleagues across Global Affairs, Legal, Communications, Product, Safety and Security, Partnerships,

re you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Regulatory Affairs Associate Consultant for 12 months Contract with possibility of extension to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. Regulatory Affairs Jr. Specialist Consultant / Especialista Jr. de Asuntos Regulatorios Location / Ubicación: Ciudad de México, México Position Summary / Resumen del puesto: Support the preparation, review and follow-up of regulatory submissions for medical devices, ensuring compliance with applicable regulations before health authorities such as COFEPRIS, enabling timely approvals and maintenance of product registrations. Apoyar en la preparación, revisión y seguimiento de trámites regulatorios para dispositivos médicos, asegurando el cumplimiento de la normativa aplicable ante la autoridad sanitaria COFEPRIS, facilitando la obtención y mantenimiento de los registros sanitarios. Key responsabilities / Responsabilidades principales: Prepare and compile regulatory documentation for COFEPRIS submissions (registrations, renewals, changes). Follow up on submissions with regulatory authority (COFEPRIS). Support interpretation of local and international regulations. Support coordination of requests and activities with cross-functional teams. Maintain updated regulatory files and databases. Preparar y compilar documentación regulatoria para sometimientos ante COFEPRIS (registros, renovaciones, modificaciones). Dar seguimiento a los trámites ante autoridad regulatoria (COFEPRIS). Apoyar en la interpretaci

Regulatory Affairs Specialist — 4 Locations. Apply via Workday.

Regulatory Affairs Intelligence Specialist — United States - Minnesota - St. Paul. Apply via Workday.

Regulatory Affairs Specialist, Medical Device — Vietnam - Hanoi. Apply via Workday.

Regulatory Affairs Specialist II — United States > Lake Forest : CP01. Apply via Workday.

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

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

Staff Regulatory Affairs Specialist (Remote) — Fremont, California. Apply via Workday.