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Senior Specialist Regulatory Affair jobs in Irvine, CA

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PRINCIPAL SPECIALIST, REGULATORY AFFAIRS ADVERTISING & PROMOTION (ONSITE)

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...

CompanyAvanos Medical
AddressAlpharetta, GA
CategorySales/marketing
Salary401(k)
Date Posted 4 days ago See detail

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 days ago seen See more...

Senior Regulatory Affairs Specialist (LC 6103)

Techdata Service Company Llc

Irvine, CA

Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, participate in developing regulatory...

2 months ago seen See more...

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.....

2 months 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 days 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 week ago seen See more...

Sr Regulatory Affairs Specialist

Johnson & Johnson

Irvine, CA

...

2 weeks 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...

2 weeks ago seen See more...

Senior Regulatory Affairs Program Lead

Johnson & Johnson

Irvine, CA

...

3 weeks 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,...

3 weeks ago seen See more...

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...

a month 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...

a month 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...

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...

a month 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...

a month 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...

a month ago seen See more...

Regulatory Affairs Specialist II

Bausch + Lomb

Remote

$65,000 - $95,000 a year

Responsible for general knowledge of pharmaceutical, consumer and medical device regulations in Regional and Local markets. Partners closely with cross-functional stakeholders to document registration strategy and implementation p...

a month ago seen See more...

Senior Manager, Regulatory Affairs

Apellis Pharmaceuticals

Remote

$132K - $167K a year

Manage, review and organize documents intended for regulatory submissions. Act as a liaison with project teams to accomplish specific regulatory deliverables (eg agency meeting briefing materials, orphan designation applications,...

a month ago seen See more...

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...

a month ago seen See more...

Senior Manager, Regulatory Affairs - Product Development

Arthrex

Naples, FL

$114K - $145K a year

Develop and implement regulatory strategies for Product Development and continuous improvement projects, ensuring alignment with business objectives and regulatory requirements. Lead assigned team(s) in establishing short-term and...

a month ago seen See more...

Senior Specialist, Communications & Public Affairs

Disney

Florida, United States

$90.8K - $115K a year

Craft communications campaigns tied to key business drivers and Public Affairs priorities Help to identify proactive storytelling opportunities to enhance DCPs reputation Conduct detailed and reliable research to provide actionab...

2 months ago seen See more...

Senior Manager, Global Product Strategy (Regulatory Affairs)

Pharming Group

United States

$125K - $158K a year

Assisting in the development of Global Product regulatory strategies. Developing regulatory timelines aligned to company strategic goals including key regulatory milestones and activities. Acting as regulatory representative on cr...

2 months ago seen See more...

Senior Specialist, Communications & Public Affairs

Disney Experiences

Florida, United States

$64.8K - $82K a year

Craft communications campaigns tied to key business drivers and Public Affairs priorities Help to identify proactive storytelling opportunities to enhance DCPs reputation Conduct detailed and reliable research to provide actionab...

2 months ago seen See more...

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...

a month ago seen See more...

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...

2 months ago seen See more...

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There are open Senior Specialist Regulatory Affair jobs in several cities including Harrisburg, Lexington, Cincinnati, Irvine, Austin, New York, Charlotte, Sunnyvale, Lenexa, Secaucus, Bothell, Columbus,

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The top companies hiring now for Senior Specialist Regulatory Affair jobs are 3M Health Care Business Group, Care/of, CONVATEC GROUP PLC, Eastridge, Enovis, EPM Scientific, Smith & Nephew,

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