Medical Affairs Manager in United States

Manager, Medical Affairs — United States - California - Foster City. 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. 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

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. 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 Kite and help create more tomorrows. Job Description This is an office based/hybrid position. The Manager, Regulatory Affairs CMC is located in El Segundo, CA, Thousand Oaks, CA, Foster City, CA or Parsippany, NJ. Kite is transitioning from its current Santa Monica headquarters, with employees expected to relocate to our Thousand Oaks, CA, El Segundo, CA, Foster City CA or Parsippany, NJ office beginning in January 2027. While this role has the option to be based in Santa Monica through 2026, applicants should take this planned relocation into consideration. Kite supports a flexible working policy, offering a balanced approach with two days of remote working and three days working onsite. Support preparation and submission of CMC regulatory filings (INDs, CTAs, BLAs, MAAs, supplements, and variations), including submissions supporting lentiviral vector (LVV) manufacturing, testing, control strategy, and lifecycl

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. 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 Kite and help create more tomorrows. Job Description Key Responsibilities Manage commercial pharmaceutical labeling projects from initiation through implementation. Coordinate labeling activities across Regulatory Affairs, Quality Assurance, Supply Chain, Manufacturing, Packaging Engineering, and external vendors. Lead artwork development, review, approval, and implementation activities. Manage project timelines, risks, priorities, and deliverables to ensure on-time execution. Review and approve artwork proofs, printer proofs, and packaging components for accuracy and compliance. Maintain labeli

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. 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 Kite and help create more tomorrows. Job Description An exciting opportunity has arisen to join the U.S. Medical Affairs Team with a focus on Lymphoma & Leukemia. In this role, you will contribute to one of the recent, most impactful medical advancements in patient care and will work towards better outcomes for patients with hematological malignancies. We are seeking a highly motivated individual to join our U.S. Medical Affairs team as an Associate Director, to support our lymphoma franchise. This role will work cross-functionally with multiple stakeholders including: Field Medical, Commercial, Market Access, HEOR/RWE and Global Medical Affairs, along with other cross-functional subject matter experts and key business partners to implement on tactics consistent with overall in-line and pipeline strategy. This position will report to the U.S. Lymphoma Medical Strategy Lead. Position will be filled and report into Foster City, CA, El Segundo, CA, T

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

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

We anticipate the application window for this opening will close on - 17 Oct 2026 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 Cranial and Spinal Technologies develops products and therapies for neurosurgical and spinal procedures, supporting physicians with technologies that improve patient outcomes. This technical writing function is responsible for developing and maintaining Instructions for Use (IFU) and related product documentation for regulated medical devices throughout the product lifecycle. The role partners closely with Product Development, Marketing, Regulatory Affairs, and other cross-functional teams to ensure documentation is accurate, compliant, and available to global users. Check us out on LinkedIn: Medtronic CST This position is based onsite in Lafayette, Colorado. Limited domestic and international travel may be required, with an expected travel commitment of less than 10%. In this role, you will develop, maintain, and manage product documentation for medical device products, including Instructions for Use (IFU), system manuals, quick reference guides, technical bulletins, and o

We anticipate the application window for this opening will close on - 25 Sep 2026 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 The Neuroscience Portfolio delivers therapies that treat disorders of the brain, spine, nerves, and vascular system. Through a broad range of medical technologies, our teams partner with physicians and healthcare systems worldwide to improve patient outcomes and quality of life. The Neurovascular Operating Unit develops technologies that treat acute ischemic stroke, hemorrhagic stroke, and other neurovascular diseases. Our portfolio includes devices designed to restore blood flow, remove clots, and treat complex vascular conditions, supporting physicians in delivering life-changing therapies to patients worldwide. This role supports the development, maintenance, and continuous improvement of stent-based neurovascular devices within a regulated medical technology environment. The engineering team partners closely with Quality, Manufacturing, Regulatory Affairs, Clinical, Supply Chain, and Marketing functions to ensure product performance, compliance, and lifecycle management are maintained while supporting patient outcomes. This is an onsite position based in Irvine, California. Travel is expected to be less than 10% and may include visits to manufacturing sites, suppliers, or company locations as

Medical Affairs Director, Rare Disease — United States > Madison : 5505 Endeavor Ln. Apply via Workday.

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. 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 Kite and help create more tomorrows. Job Description We are seeking a Medical Strategy professional to join the Global Medical Strategy team for Lymphoma and Leukemia. This role partners closely with the Global Medical Lymphoma/Leukemia lead to support the development and execution of medical strategy across the product lifecycle, including marketed products and pipeline indications. The position collaborates cross‑functionally with internal partners and external experts to ensure the generation and communication of scientific evidence that supports optimal patient outcomes in hematologic malignancies. An exciting opportunity has arisen to join the Global Medical Strategy Team for Lymphoma and Leukemia (LL). In this role, the right candidate will receive a great opportunity to be part of one of the recent most impactful medical advancements in patient care and an opportunity to work towards better outcomes for patients with hematological malignancies. <p

We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one community at a time. Job Purpose and Summary: Join a mission-driven organization at a transformative moment in employer-sponsored health care. As Executive Medical Director, Clinical Business Solutions at Aetna, a CVS Health company, you will lead the clinical team that serves as the clinical voice to our Commercial plan sponsors, prospects, and their advisors, demonstrating how Aetna’s clinical capabilities reduce cost, improve population health, and strengthen the member and provider experience. Reporting directly to the Vice President, Chief Medical Officer, Commercial & Innovation, you will direct a national team of clinicians (MD, RN, NP) providing clinical support to Aetna’s National Accounts, Large Group, and Public & Labor businesses, in close partnership with Field and Account teams. You will lead and continuously improve the operations of the team to raise the level and quality of clinical support delivered to the Field, while sharing directly in its external work — including personally cultivating and holding relationships with key brokers, consultants, and plan sponsors. The role is deliberately bidirectional. You will bring the voice of the customer and the producer community back into the organization, partnering with Clinical Operations, Medical Affairs, Commercial Product, and others to ensure our clinical offerings reflect what the market requires. <p

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

We anticipate the application window for this opening will close on - 29 Sep 2026 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&#43; 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 The Supplier Quality function partners with Contract Manufacturers (CMs), Original Equipment Manufacturers (OEMs), and critical suppliers to ensure the quality, compliance, and performance of externally manufactured products and components. This team works cross-functionally with Research & Development (R&D), Quality, Regulatory Affairs, and Operations to support product lifecycle activities, drive supplier performance improvements, and maintain compliance with applicable quality system and regulatory requirements. This position may be performed remotely anywhere within the United States. Travel up to 15% is required to support supplier audits, supplier performance reviews, business meetings, and cross-functional initiatives. The Senior Supplier Quality Engineer serves as the primary quality partner for strategic Contract Manufacturers and Original Equipment Manufacturers, ensuring supplier processes, products, and quality systems consistently meet Medtronic requirements. This role drives supplier quality performance, supports product and process changes, leads quality improvement initiatives, and provides technical quality guidance across supplier-related activities throughout the product lifecycle. Primary Responsi

We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one community at a time. Position Summary: Ready to take your Medical Director career to the next level with a Fortune 6 company? Join Aetna, a CVS Health company, and make a meaningful impact on the health and well-being of Medicaid members across the country. Aetna operates Medicaid managed care plans in Arizona, Florida, Illinois, Kentucky, Louisiana, Maryland, Michigan, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, and West Virginia. We are seeking a Medical Director to join our centralized Medical Management team. This work-from-home position will primarily support Aetna Better Health of Louisiana , while also providing support across the other health plans as needed. In this role, you will partner with Medical Management staff to ensure timely, consistent, and clinically sound decisions for members and providers. Key responsibilities include: Utilization Management and medical necessity reviews Prior authorization and precertification determinations Concurrent review for inpatient and outpatient services Acute and post-acute care reviews Peer-to-peer consultations with treating providers Pharmacy reviews and first-level appeal determinations Collaboration with multidisciplinary clinical and operational teams The Medical Director also participates in a rotating on-c