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Senior Regulatory Affair Specialist jobs in Irvine, CA

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REGULATORY AFFAIRS SPECIALIST III

Under direct supervision of the RA Project Manager, or Department Manager, assists in preparing moderately complex submissions to gain approvals for clinical research, export, and commercial distribution, such as: IDE, IDES, IDE...

CompanyBoston Scientific
AddressMaple Grove, MN
CategoryInformation Technology
Date Posted a week ago See detail

Regulatory Affairs Specialist III

Boston Scientific

Maple Grove, MN

Under direct supervision of the RA Project Manager, or Department Manager, assists in preparing moderately complex submissions to gain approvals for clinical research, export, and commercial distribution, such as: IDE, IDES, IDE...

a week ago seen See more...

Regulatory Affairs Specialist

Convatec

Lexington, MA

$49.4K - $62.5K a year

Directing submission development of product registration, progress reports, supplements, amendments, and/or periodic experience reports Providing strategic product direction to teams on interaction and negotiating evidence with re...

3 weeks ago seen See more...

Sr Regulatory Affairs Specialist

Johnson & Johnson

Irvine, CA

...

a month ago seen See more...

Senior Regulatory Affairs Program Lead

Johnson & Johnson

Irvine, CA

...

2 months ago seen See more...

Principal Regulatory Affairs Specialist (medlance.co)

Medlance

Remote

$30 - $300 an hour

Lead regulatory strategy development for medical device projects. Manage submissions to regulatory bodies. Advise on regulatory requirements and changes. Collaborate with cross-functional teams for regulatory compliance. Extensive...

2 months ago seen See more...

Regulatory Affairs Specialist

Redbock- An Nes Fircroft Company

Remote

$70.9K - $89.8K a year

Prepare and maintain international submission dossiers. Prepare electronic pre-market and post-market regulatory submissions. Compile Technical Documentations for IVD medical devices. Monitor progress on project deliverables and p...

2 months ago seen See more...

Regulatory Affairs Specialist

Brs

Remote

$62.1K - $78.7K a year

Contractor shall have at least 5 years experience applying FDA research regulatory requirements within a research Regulatory Affairs program office. Work in preparing ones own research proposals and ones own submissions to an IR...

2 months ago seen See more...

Principal Specialist, Regulatory Affairs Advertising & Promotion (Onsite)

Avanos Medical

Alpharetta, GA

401(k)

Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do;. Making a difference in how we work and collaborate, constantly nurturing our nimble culture of inn...

4 weeks ago seen See more...

Senior Manager, Regulatory Affairs Vendor Governance

Biospace

California, United States

Own initiatives and day to day responsibilities in support of vendor oversight within RA. Negotiation and problem solving between Gilead RA leads and Vendor resources. Able to gather information or assign tasks or activities for o...

4 weeks ago seen See more...

Sr. Specialist, Regulatory Affairs CMC

Biospace

United States

Prepare content of CMC documentation for large and small molecule product submissions to regulatory agencies (FDA/EMA), ensuring accuracy, completeness, and consistency with strategy. Review and edit final documents for regulatory...

a month ago seen See more...

Senior Manager/Associate Director of Regulatory Affairs

Tempus

Chicago, IL

Developing and leading global regulatory strategies to support business objectives. Leading submissions and correspondence with global regulatory authorities, including 510(k),PMA, De Novo authorizations, IDE, MDR CE marking, UKCA...

a month ago seen See more...

Senior Associate of Regulatory Affairs, CMC

Meitheal Pharmaceuticals Inc

Chicago, IL

Other duties may be assigned. Serves as the primary regulatory interface with global US FDA manufacturing partners , and internal teams to ensure the business needs for the assigned products are met by anticipating, identifying,...

a month ago seen See more...

Regulatory Affairs Senior Consultant

Medenvoy Global Bv

Remote

From $100,000 a year

Reviewing and processing of serious incidents related of medical devices of customers. Supervision of field safety corrective actions performed by clients. Communication with competent authorities and clients. Addressing post mark...

2 months ago seen See more...

Senior Manager, Regulatory Affairs Biocides - Remote

Steris

Alpharetta, GA

Home Based / Remote opportunity. 20% Domestic Travel Required. 10% International Travel Required. Identify and keep current with the various US EPA, EU BPR and other international country submission/registration/approval and compl...

2 months ago seen See more...

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