Full-Time Senior Specialist Regulatory Affair jobs in Irvine, CA

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SENIOR REGULATORY AFFAIRS SPECIALIST

Regulatory affairs experience with Class II and III medical devices. Outside of the US experience is preferred on top of domestic experience, specifically the EU.. Proven track record of developing written RA plans & strategies.....

CompanyUltimate Staffing Services
AddressIrvine, CA
CategoryInformation Technology
Job typeFull-Time
Date Posted 2 months ago See detail

Senior Regulatory Affairs Specialist

Ultimate Staffing Services

Irvine, CA

Regulatory affairs experience with Class II and III medical devices. Outside of the US experience is preferred on top of domestic experience, specifically the EU.. Proven track record of developing written RA plans & strategies.....

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...

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...

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,...

Senior Regulatory Affairs Advisor

Cook Device Solutions

Remote

$100,000 - $125,000 a year

Authors submissions and other regulatory documents to obtain approval to bring new or modified products to market, including but not limited to FDA 510(k) submissions and EU MDR Technical Files. Manages communications with regulat...

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...

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...

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...

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...

Senior Manager, Regulatory Affairs, CMC

Beigene

Remote

$133,400 - $178,400 a year

Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high- quality global submissions for investigational, market, and post-appro...

Senior Counsel, Regulatory & Legislative Affairs

The Clearing House

Remote

$135K - $171K a year

JD and Licensed attorney, preferably in NY or DC. 5-10 years experience working on payments-related matters in a law firm, bank, or regulatory agency, or on advocacy for the financial industry. Demonstrated ability to quickly gra...

Senior Public Affairs Specialist

Peraton

Maryland, United States

$112,000 - $179,000 a year

Assist in leading efforts for the planning and implementation of a comprehensive Public Affairs program for the Cyber National Mission Force, a sub-unified command subordinate to USCYBERCOM. Assist in leading coordination efforts...