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Full-Time Regulatory Affair Specialist jobs in Irvine, CA

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REGULATORY AFFAIRS SPECIALIST

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...

CompanyRedbock- An Nes Fircroft Company
AddressRemote
CategoryInformation Technology
Salary$70.9K - $89.8K a year
Job typeFull-time | Contract
Date Posted a month ago See detail

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 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...

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...

3 weeks ago seen See more...

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...

6 days ago seen See more...

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...

a week 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...

2 weeks ago seen See more...

Clinical Research Regulatory & Quality Specialist

Insight

Chicago, IL

Able to provide eligibility for employment for any U.S. employer Bachelors Degree in Research Science or related field required Masters Degree desired in related field to Clinical Sciences Strong working knowledge of FDA CFR 21...

a week ago seen See more...

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...

3 weeks ago seen See more...

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...

3 weeks ago seen See more...

Budget Specialist for Academic & Student Affairs

Georgia Gwinnett College

Georgia, United States

4 Year / Bachelor's Degree. Three (3) years of experience in higher education. Five (5) years of experience in a general office environment with accounting experience. Graduate Degree. Three or more years of experience in higher e...

3 weeks ago seen See more...

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...

4 weeks ago seen See more...

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...

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...

a month ago seen See more...

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...

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 Specialist - US

Deephealth

Remote

$74.9K - $94.8K a year

Plan, define and coordinate relevant process related to product Regulatory approval, including but not limited to, FDA clearance, and/or CE Marking. Actively liaise and closely collaborate with engineering and product teams to ens...

a month ago seen See more...

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...

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...

2 months ago seen See more...

Director, Regulatory Affairs Advisor & Liaison

Capital One

Virginia, United States

Enjoy working with banking regulators Closely follow digital and technological developments in banking and financial services Understand and appreciate technology and cyber security risk management Relish interacting with senior l...

2 months ago seen See more...

(Medical Physicist) Clinical Affairs Specialist

Radformation

Remote

$120,000 - $190,000 a year

Assist in the preparation of regulatory submissions and impact assessments. Perform clinical evaluation plans and reports. Perform literature searches and reviews. Perform usability evaluation plans and reports. Assist in validati...

2 months ago seen See more...

Regulatory Affairs Manager - Electrophysiology

Abbott Laboratories

Minnesota, United States

$95,000 - $190,000 a year

Career development with an international company where you can grow the career you dream of. Free medical coverage for employees* via the Health Investment Plan (HIP) PPO An excellent retirement savings plan with high employer con...

2 months 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...

2 months ago seen See more...

Sr. Manager, Regulatory Affairs CMC (Remote)

Ptc Therapeutics

Remote

Leads and manages the development of Module 2 and 3 CMC documents for regulatory filings such as INDs/IMPDs/CTAs and MAAs/NDAs/ global registrations and eCTD submissions, ensuring that they meet current regulatory standards and ar...

2 months ago seen See more...

Regulatory Affairs Project Manager

Endologix

Irvine, CA

$104,000 - $165,000 a year

Represent RA department in assigned project meetings and provide regulatory guidance to ensure adherence with global regulatory requirements as appropriate. Maintain up-to-date knowledge on domestic and international regulatory re...

2 months ago seen See more...

Regional Manager of Quality & Regulatory Affairs

Alaska Dialysis

Alaska, United States

$81.7K - $103K a year

Responsible for overseeing regulatory and growth perspective in accordance with Company goals. Assist in clinical operational development and transition of new or acquired clinic(s) as needed or requested. Assess and integrate cli...

2 months 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...

2 months ago seen See more...

Regulatory Risk Specialist

Northern Trust

Chicago, IL

Unspecified

Responsible for supporting the definition and leading the execution against the identified pillars of the Program as a named Program Lead. Collaborating with stakeholders across all lines of defense, multiple business units and se...

4 weeks ago seen See more...

Specialist - Regulatory Reporting

Northern Trust

Chicago, IL

Unspecified

Bachelor's degree in relevant field (e.g. Finance, Accounting, Economics, etc). Minimum 10+ years of experience in financial services or a related industry, with a significant focus on Regulatory Reporting, compliance, and financi...

4 weeks ago seen See more...

Mid-Level Environmental Regulatory Compliance Specialist

Endyna

Virginia, United States

$90,000 - $100,000 a year

About the Role Mid-Level Environmental Regulatory Compliance Specialist with direct experience in multi-media audits. Perform limited field sampling; perform environmental compliance audits; conduct complex technical analyses/calc...

a month ago seen See more...

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What companies are hiring for Full-Time Regulatory Affair Specialist jobs in California?

The top companies hiring now for Full-Time Regulatory Affair Specialist jobs are Abbott, Alphatec Spine, bioMérieux, Burt's Bees, Chemence, CooperVision, Cutera, Eastridge, enVista, Genus PLC, Teleflex, Thermo Fisher Scientific, Tosoh Bioscience, Inc., University of Pennsylvania, Vantage Specialty Chemicals,

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