Regulatory Affairs Specialist

We anticipate the application window for this opening will close on - 24 Nov 2025At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeThis is an ONSITE...

A minimum of a Bachelor's degree, preferably in a scientific or technical discipline A minimum of 5 years work experience in Regulatory Affairs or a related discipline in medical devices (R&D, Quality, Clinical, Medical Affairs, Biocompatibility) Demonstrated experience of the regulatory requirements associated with implantable or active implantable medical...

Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close...

Regulatory Affairs and Compliance AssociateLocation:Irvine, CACompany:ELIXIR MD Inc.Industry:Medical Devices (Global Aesthetic & Surgical Markets)About UsELIXIR MD Inc. is a fast-growing fully integrated medical device innovator, headquartered in Irvine, CA. and proud Made in the USA ethos. Our manufacturing, supply, sales and support operations are global...

Job SummaryThe Director of Regulatory Affairs, JAPAC is responsible for leading the development and execution of regulatory strategies to ensure timely market access and compliance for Masimo's medical devices across Japan and the Asia-Pacific region. This role partners with regional leadership, regulatory authorities, and cross-functional teams to navigate...

ResponsibilitiesResponsible for providing guidance to ensure that all regulatory submissions are planned, communicated, and performed per regulatory and business requirements. In addition, this position serves as a subject matter expert on various regulations, coordinating regulatory issue resolution through the use of internal resources, regulatory...

Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close...

Key Responsibilities:Support US and EU regulatory submissions (exercising judgment to protect proprietary information); track timelines and document milestone achievements.Participate in assessing and collating regulatory impact and developing regulatory strategy.Collaborate and approve change requests/change notifications.Participate in providing guidance...

Position: Medical Affairs Analyst,Req#: Location: Irvine, CA (100% Onsite), 8:00 AM PST to 5:00 PM PSTDuration: 12+ Month Contract (Possibilities of extension)Job Description:This is a unique opportunity to play an important role in the growing Transcatheter Mitral & Tricuspid Therapies (TMTT) Medical Affairs team, providing innovative solutions to transform...

Job SummaryJOB DESCRIPTIONThe Project Manager, Regulatory Affairs will be responsible for planning, coordinating, and executing projects that support regulatory and quality compliance across Masimo's medical device portfolio. These projects may include regulatory submissions, remediation activities, compliance with international regulations (e.g., EU MDR,...