Regulatory Affairs Specialist IVD Jobs in USA

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Medical Device Regulatory Affairs Development (rad...

Abbott

profile Alameda - USA

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 115000 collea...

30+ days ago
Full Time

Regulatory Affairs Specialist

Real Soft Inc

profile Madison Heights - USA

Qualifications Bachelors Degree in Chemistry Biology Toxicology or related field. Experience in professional level position in business. Experience with OSHA/TSCA/RCRA/Export regulations desirable. Ability to manage multiple projects while effectively communicating status to senior staff. Excellent...

30+ days ago
Full Time

Intern Regulatory Affairs

Inx International Ink Co.

profile West Chicago - USA

This role offers a rate of $22.00 per hour at this location. The compensation is fixed and does not vary based on qualifications.We are seeking a motivated Regulatory Affairs Intern to support core regulatory compliance activities including chemical data management and regulatory research while gain...

30+ days ago
Part-time

Regulatory Affairs Specialist

Heraeus Group

profile Fridley - USA

Regulatory Affairs SpecialistFridleyAbout HeraeusMaking displays foldable Helping hearts beat with medical innovations Or breathing new life into precious metals As a family-owned global technology group we help our customers to always being one step ahead.About Heraeus MedevioTogether we improve li...

30+ days ago
Full Time

Senior Staff Regulatory Affairs Specialist

Stryker

profile Irvine - USA

Work Flexibility: Hybrid or OnsiteSenior Staff Regulatory Affairs SpecialistIrvine CaliforniaAs a Senior Staff Regulatory Affairs Specialist you will influence global regulatory strategy across the full product lifecycle while partnering closely with product development quality and clinical teams. T...

30+ days ago
Full Time

Associate Director, Regulatory Affairs

Baxter

profile Deerfield - USA

This is whereyour work makes a difference.At Baxter we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater...

30+ days ago
Full Time

Staff Regulatory Affairs Engineer

Hinge Health

profile San Francisco - USA

About The RoleThe Staff Regulatory Affairs Engineer is the primary regulatory strategist and architect for our AI/ML Software as a Medical Device (SaMD) portfolio. While many companies view Regulatory Affairs as a purely administrative function at Hinge Health we leverage this role as a technical di...

30+ days ago
Full Time

Manager, Regulatory Affairs Cmc

Kite Pharma

profile Santa Monica - USA

Were 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. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we...

30+ days ago
Full Time

Manager, Regulatory Affairs Device-combination Pro...

Abbvie

profile Irvine - USA

The Manager Regulatory Affairs Device works with internal and external partners to deliver products to patients. Prepares device regulatory strategies that enable first pass approvals under limited management supervision. Develops and manages content strategy for global regulatory submissions includ...

30+ days ago
Full Time

Manager, Regulatory Affairs Device-combination Pro...

Abbvie

profile North Chicago - USA

The Manager Regulatory Affairs Device works with internal and external partners to deliver products to patients. Prepares device regulatory strategies that enable first pass approvals under limited management supervision. Develops and manages content strategy for global regulatory submissions includ...

30+ days ago
Full Time

Senior Regulatory Affairs Professional

Versiti

profile Aurora - USA

OverviewVersiti is a fusion of donors scientific curiosity and precision medicine that recognize the gifts of blood and life are precious. We are home to the world-renowned Blood Research Institute we enable life saving gifts from our donors and provide the science behind the medicine through our di...

30+ days ago
Full Time

Sr. Regulatory Affairs Specialist Ii

Treace

profile Others - USA

POSITION SUMMARY:The Senior Regulatory Affairs Specialist II will report to the Director of Regulatory Affairs and will work with Product Development Quality Operations and Marketing to support the product development process and meeting all applicable regulatory requirements. The Senior Regulatory...

30+ days ago
Remote

Regulatory Affairs Specialist Fully Remote

Mercor

profile New York City - USA

About the job Mercor connects elite creative and technical talent with leading AI research labs. Headquartered in San Francisco our investors include Benchmark General Catalyst Peter Thiel Adam DAngelo Larry Summers and Jack Dorsey. Position: Medical Devices Expert Type: Contract Compensation: $55$7...

30+ days ago
Full Time

Compliance Expert Regulatory Affairs

Mercor

profile San Francisco - USA

About the job Mercor connects elite creative and technical talent with leading AI research labs. Headquartered in San Francisco our investors include Benchmark General Catalyst Peter Thiel Adam DAngelo Larry Summers and Jack Dorsey. Position: Compliance & Regulatory Expert Type: Contract Compensatio...

30+ days ago
Full Time

Regulatory Affairs Specialist Onsite

Medtronic

profile Minneapolis - USA

We anticipate the application window for this opening will close on - 16 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...

30+ days ago
Full Time

Senior Regulatory Affairs Specialist Onsite

Medtronic

profile Minneapolis - USA

We anticipate the application window for this opening will close on - 16 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...

30+ days ago
Full Time

Sr. Manager, Regulatory Affairs

Johnson & Johnson

profile Brunswick - USA

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are unique...

30+ days ago
Full Time

Director, Regulatory Affairs Advanced Technology E...

Abbvie

profile North Chicago - USA

The Director Regulatory Affairs Advanced Technology Enablement is responsible for shaping owning and executing the Regulatory Affairs (RA) AI roadmap driving strategic initiatives that embed artificial intelligence and automation within the global RA organization. This leader will serve as the key s...

30+ days ago
Full Time

Sr Director, Regulatory Affairs Cmc

Kite Pharma

profile Santa Monica - USA

Were 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. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we...

30+ days ago
Full Time

Senior Director, Grs Oncology, Global Regulatory A...

Gsk

profile Waltham - USA

Business IntroductionAt GSK we have bold ambitions for patients aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines combining our understanding of the immune system with cutting-edge technology to...

30+ days ago
Full Time