Regulatory Affairs Jobs in USA

At PGE our work involves dreaming about planning for and realizing a smarter cleaner more enduring Oregon neighborhood. Its core to our DNA and we havent stopped since we started in 1888. We energize lives strengthen communities and drive advancements in energy that promote social economic and envir...

Position: Senior CAPA FDA Lead Location: Bothell Washington Job Description Key Responsibilities Lead FDA audit and inspection readiness activities across the organization. Serve as the primary presenter and point of contact during FDA inspections audits and regulatory meetings. Present CAPA effec...

We are seeking a skilled SharePoint / Excel Developer to support business operations reporting and collaboration initiatives within a growing biotechnology organization. This role will focus on developing and maintaining SharePoint-based solutions advanced Excel reporting tools workflow automation a...

Job Title : European Union Medical Device Regulation Auditor Location: Austin TX Duration: 6 months Key Responsibilities: Plan scope and lead comprehensive mock audits to assess readiness for an upcoming BSI notified body audit. Evaluate the medical device manufacturers Quality Management System...

The Associate Regulatory Affairs Submission Management manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams. The Associate establishes and maintains submission content planners and associated timelines facilitates tactical submission team m...

The Associate Regulatory Affairs Submission Management manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams. The Associate establishes and maintains submission content planners and associated timelines facilitates tactical submission team m...

The Senior Designer Collaborative and Visual Design Services is a multi-disciplined creative and expert technologist who serves as the lead hybrid designer and developer delivering end-to-end digital experiences for Regulatory Affairs and the RA Advanced Capabilities team. The Senior Designer design...

We are looking for an experienced and versatile Senior Scientist I/Development Engineer to join our Injection Device Development team to help us accelerate AbbVies combination products from proof-of-concept through submission industrialization and launch.Our team has end-to-end accountability for co...

Primary Function of Position:The Contract Negotiator is key in Intuitives commercial contracting. As the main communicator for sales contracts the Contract Negotiator works with Intuitives salesforce leadership internal management over 10 departments and customers for compliance and mitigation of ri...

Primary Function of Position:The Contract Negotiator is key in Intuitives commercial contracting. As the main communicator for sales contracts the Contract Negotiator works with Intuitives salesforce leadership internal management over 10 departments and customers for compliance and mitigation of ri...

Primary Function of Position:Intuitive Surgical designs and manufactures highly complex surgical systems includingcameras instruments and accessories for use in surgery. We are looking for a strongquality functional leader to support the projects associated with the development of nextgeneration pro...

We anticipate the application window for this opening will close on - 30 May 2026At 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 more connected c...

About HarriIts a great time to join Harri as we revolutionize the hospitality industry with our cutting-edge technology solutions for workforce management. Were an innovative high-growth company with a global presence dedicated to building strong partnerships and delivering measurable value to our c...

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 aga...

The Role:The candidate in this role will be based at the Norwood MA site and will be responsible for preparing and overseeing CMC and Quality related agency correspondence and regulatory applications as well as govern CMC submissions and regulatory compliance support for the development of global pr...

DescriptionArdelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative purpose-driven culture we strive to create meaningful impact for patients.Team Arde...

DescriptionArdelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative purpose-driven culture we strive to create meaningful impact for patients.Team Arde...

At Alexion Rare Disease everything we do is underpinned by our dedication to being a Great Place to Work. Put simply our people are our greatest asset. We know that with a talented brave and diverse team that believes in making a meaningful impact for people living with rare diseases every day incr...

At Alexion Rare Disease everything we do is underpinned by our dedication to being a Great Place to Work. Put simply our people are our greatest asset. We know that with a talented brave and diverse team that believes in making a meaningful impact for people living with rare diseases every day incr...

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...