Associate Regulatory Affairs Jobs in USA

We anticipate the application window for this opening will close on - 7 Aug 2025At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a mo More...

Responsibilities: Prepare and submit new global market device applications and amendments. Prepare and oversee the review of Traditional 510(k) Premarket Notifications. Develop and implement regulatory filing timelines for new and existing products in key markets such as US EU and As More...

Responsibilities: Manage assigned projects to ensure thoroughness accuracy and timeliness of CMC dossiers and responses. Partner with RA CMC Project Leads and develop module 3 content and project timelines. Collaborate with diverse functional groups to ensure file-ability and accepta More...

The Senior Manager Regulatory Affairs Chemistry Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submiss More...

Career CategoryRegulatoryJob DescriptionHOW MIGHT YOU DEFY IMAGINATIONYouve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills experience and passion to work toward your goals At Amgen our shared mi More...

Principal Associate Regulatory Risk and GovernanceCapital One is one of the fastest growing organizations in the world today. As a Principal Associate you will apply your risk management and project management skills in our Regulatory Risk and Governance team to support the implementa More...

OverviewSupport the Regulatory Affairs (Executive Director) in developing and executing regulatory strategies for antiviral programs globally or within specific regionsResponsibilitiesAssisting in preparing presentations reports and strategic documents for leadership discussions.Maint More...

ABOUT HOUSING CALIFORNIASince 1988 Housing California (Housing CA) has worked to create a California with homes health and prosperity for all in thriving sustainable communities. We bring together a diverse cross-sector network to prevent and end homelessness increase the supply of sa More...

See Yourself at TelixTo support the Groups strategic objectives the Regulatory Affairs Manager Japan will oversee Regulatory Affairs for clinical and commercial registration activities of Telix portfolio in Japan. This role involves conducting regulatory tasks related to new product d More...

BandLevel 4Job Description Summary#LI-Hybrid #LI-OnsiteIn this role you will be a part of the Regulatory team within Navigate and will be primarily responsible for providing strategic product direction as well as directing and coordinating the submission of regulatory documents for r More...

The Senior Regulatory Affairs Specialist plays a critical role in ensuring regulatory compliance and supporting cross-functional teams in the preparation submission and tracking of regulatory documentation. This position requires strong collaboration communication and analytical skill More...

We anticipate the application window for this opening will close on - 26 Jul 2025At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a m More...

Responsibilities: The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance in the design manufacturing and sales of medical devices (including Class I and II devices software as a medical device). More...

Job DescriptionGRACS CMC Associate Principal Scientist CMC R4 Pharm Pre-approval Reporting to the Sr Director/Director/Principal Scientist/Sr Principal Scientist in Pre-approval Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our compa More...

OverviewThe Director Regulatory Affairs is responsible for leading the day-to-day activities of Regulatory Affairs with specific emphasis on global regulatory submission strategy regulatory submissions adverse event reporting / field actions and interaction with global regulatory auth More...

Responsibilities: Regulatory Labelling Documentation. Support the creation and maintenance of assigned labelling projects to enable worldwide regulatory submissions. Independently prepare and maintain the Tracking Sheets for the global regulatory dossiers related to labelling project More...

Responsibilities: In this critical role you will lead regulatory strategies product submissions and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA) EU (MDR) China (NMPA) an More...

The Senior Administrative Assistant will support the broader Regulatory Affairs organization including Strategic Medical Writing and Ad Promo. The Senior Administrative Assistant is responsible for all administrative functions of the department: answering phones managing calendars sch More...

Summary:Provides regulatory support to all preapproval and post approval activities for new products and existing products through products lifecycle. Prepares and compiles drug product regulatory documents. Provides regulatory guidance to matters related to product development.Primar More...

We anticipate the application window for this opening will close on - 4 Aug 2025At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a mo More...