Regulatory Affair 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...
| Company | Boston Scientific |
|---|---|
| Address | Maple Grove, MN |
| Category | Information Technology |
| Date Posted | 7 days 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...
7 days ago seen See more...
- View all - jobs in Maple Grove, MN
Manager, Global Regulatory Affairs CMC Submissions Management - Now Hiring
Takeda Pharmaceutical
New York, United States
$138,500 - $186,000 per year
I further attest that all information I submit in my employment application is true to the best of my knowledge.Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in...
3 weeks ago seen See more...
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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...
- View all - jobs in Lexington, MA
Associate Director, Regulatory Affairs Innovation
Biospace
Irvine, CA
Leads and/or supports medical device / pharma development, including Clinical Outcome Assessment tools and Digital Health Technologies, and global filing activities from a regulatory standpoint from initial product concept through...
3 weeks ago seen See more...
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Regulatory Affairs Associate - North Chicago, United States - Validation Associates
Validation Associates
United States
As the professional in the Regulatory Affairs function, the individual will assist teams in the registration of products by preparing documentation needed for registration in EURI/MENAP global. Individual shall develop partnership...
4 weeks ago seen
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...
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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...
- View all Biospace jobs - jobs in California State
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...
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Associate Director, Regulatory Affairs Advertising and Promotion
Biospace
California, United States
Provides commercial regulatory support to high-volume brands or therapeutic area and projects without managerial oversight, as appropriate. Reviews and approves promotional materials.. Serves as PRC Chair for one or more high-volu...
a month ago seen See more...
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Regulatory Affairs Manager - Now Hiring
Abbott Laboratories
Texas, United States
$95000 - $190000 per year
Develops sound global regulatory strategies for new and modified medical devices. Prepares robust regulatory applications to achieve departmental and organizational objectives. Creates, reviews and approves engineering changes. Pr...
a month ago seen See more...
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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...
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Manager, Regulatory Affairs
Invenergy
Chicago, IL
Monitor, coordinate and lead advocacy efforts at state economic and environmental regulatory bodies (public utility commissions, public service commissions, utility boards, state procurement entities, state EPA or siting authoriti...
a month ago seen See more...
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Manager - Regulatory Affairs
Biospace
Lexington, MA
Compile, submit and maintain applications (IND, CTAs, NDAs etc.) to regulatory agencies in support of investigational and marketed products, including compiling and submitting responses to agency queries. Create and maintain produ...
a month ago seen See more...
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Director, Digital Health Regulatory Affairs
Mcra
West Virginia, United States
Develop and execute regulatory services for client companies, including however not limited to:. Regulatory Submissions (510(k), IDE, PMA, De Novos, BLA, & IND). Regulatory Strategy, Analysis & Development. Design, Review & Implem...
a month ago seen See more...
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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...
Manager Regulatory Affairs
Philip Morris
Washington, United States
Were totally transforming our business and building our future on one clear purpose to deliver a smoke-free future.In late 2022, PMI acquired Swedish Match and its leading oral nicotine product portfolio. Monitors & facilitates...
2 months ago seen See more...
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Regulatory Affairs Manager
Freudenberg Group
Remote
$94.6K - $120K a year
Provide regulatory excellence to the organization and guide decision making Responsible to direct, coordinate and supervise activities of Regulatory Affairs staff. Establish project priorities, ensure resources are available and b...
2 months ago seen See more...
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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...
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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...
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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...
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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...
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Director, CMC Regulatory Affairs Biologics
Biospace
California, United States
Lead CMC regulatory strategy for a single or multiple products. Lead the execution and influence the development of global CMC regulatory strategies, including risk mitigation strategies to ensure right first-time approvals of pro...
2 months ago seen See more...
- View all Biospace jobs - jobs in California State
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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Associate Director, Regulatory Affairs - West Chester, PA
Teva Pharmaceuticals
United States
Spearhead the delivery of successful investigational and regulatory license applications and product life cycle management submissions with the Global Regulatory Affairs Team from initial filing through post-approval management. P...
2 months ago seen See more...
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