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SR. REGULATORY AFFAIRS SPECIALIST - CARDIAC DIAGNOSTICS CDX

Supports the development of domestic and international strategies for regulatory approval of Class I, II and III medical devices. Coordinates, compiles, and submits U.S. and EU regulatory filings for new and modified products, inc...

CompanyBoston Scientific
AddressHills, MN
CategoryInformation Technology
Date Posted 4 weeks ago See detail

Sr. Regulatory Affairs Specialist - Cardiac Diagnostics CDx

Boston Scientific

Hills, MN

Supports the development of domestic and international strategies for regulatory approval of Class I, II and III medical devices. Coordinates, compiles, and submits U.S. and EU regulatory filings for new and modified products, inc...

Regulatory Affairs Senior Program Manager

Biospace

San Francisco, CA

6+ years of Regulatory Affairs experience in the biopharmaceutical industry or equivalent Pref Knowledge of regulatory requirements and early to mid-clinical stage experience with US regulatory submissions for therapeutic products...

Manager, Regulatory Affairs CMC

Pix11

New York, NY

The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, c...

Senior Regulatory Affairs Program Lead

Johnson & Johnson

Raynham, MA

...

Senior Regulatory Affairs Program Lead

Johnson & Johnson

Irvine, CA

...

Manager, Regulatory Affairs CMC - Now Hiring

Takeda Pharmaceutical

Bronx, NY

The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, c...

Clinical Research, Regulatory Associate (PHX)

Castle Biosciences

Phoenix, AZ

Minimum Requirements High School diploma or GED equivalent, or equivalent experience required. Familiarity with research and development processes Working knowledge of S., European, and/or global regulations and standards covering...

Manager, Regulatory Affairs CMC

Biospace

Boston, MA

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 in Cambridge, MA with the...

Associate Vice President, International Government Affairs

Biospace

Washington, United States

Be the accountable single point of contact for International Government Affairs and direct liaison for the Executive VP of Lilly International Business Unit. Lead the International vision and strategy, planning and achieving of hi...

Director, Regulatory Affairs

Biospace

San Diego, CA

Accountable for the development and implementation of the regulatory strategy for AnaptysBios pipeline programs. Serve as the FDA contact, leading creative and constructive interactions with regulatory agencies to effectively neg...

Sr. Manager of Regulatory Affairs/ In-House Counsel at Software Company

Alchemy Legal

Los Angeles, CA

Lead and manage collections efforts, including developing strategies, negotiating settlements, and overseeing litigation processes. Handle litigation matters, including case management, legal research, and representation in legal...

Regulatory Affairs Analyst

Brycetech

Washington, DC

CBRN Research and Analysis. CBRN Policy and Doctrine Support. Special Projects. Policy support to the Federal Radiological Preparedness Coordinating Committee (FRPCC). Planning support to the Chemical, Biological, Radiological/Nuc...

Sr. Project-Program Manager, Regulatory Affairs

Arthrex

Naples, FL

Manages subsidiary-based and global projects/programs within the scope of the Regulatory Affairs.. Develops project objectives by reviewing project proposals and business plans, conferring with senior management and key stakeholde...

Regulatory Affairs Manager Regional Regulatory Lead

Biospace

Washington, DC

Implement the US regulatory plan and obtain and maintain Clinical Trial Authorizations and Marketing Application approvals in the US. Provide content for and coordinate US regulatory documents and meetings in accordance with GRT s...

SVP, Global Regulatory Affairs

Biospace

Waltham, MA

Ensure the development, preparation, and implementation of global strategic regulatory plan for all programs and product pipeline designed to maximize successful and expedient global product registrations. Responsible for managing...

Manager, Regulatory Affairs CMC - Now Hiring

Takeda Pharmaceutical

Brooklyn, NY

The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, c...

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...

Licensing & Regulatory Affairs Analyst

Sportradar

Las Vegas, NV

Tracking sports betting and iGaming legislative and regulatory efforts of new and existing jurisdictions with special focus on licensing requirements. Research, populate, and maintain internal library of country specific regulator...

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...

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...

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...

Sr. Regulatory Affairs Specialist

Oxenham Group Llc

Saint Paul, MN

Writing and updating technical files to meet applicable regulatory requirements, to included Essential Requirements, General Safety and Performance Requirements, Device classification, compiling technical documentation, identifica...

Principal Regulatory Affairs Specialist

Vertos Medical, Inc

Aliso Viejo, CA

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Mental Demand Moderate to high degree of concentration due to volume, complexity, and/or pressure of work. Abil...

Staff/Principal Regulatory Affairs Specialist (Operations)

Recor Medical

Palo Alto, CA

Manages post market activities, including but not limited to EU MDR and MEDDEV compliant Clinical Evaluation documents for new products and maintain/update existing company Clinical Evaluation Plans (CEPs), Clinical Evaluation Rep...

Senior Regulatory Affairs Specialist

Iconma, Llc

Saint Paul, MN

This position will be working with multiple business units to develop, update, and improve regulatory affair processes. Assist the strategy implementation and operations for Regulatory Affairs activities, including directing devel...

Senior Regulatory Affairs Specialist

Axelon

Saint Paul, MN

This position will be working with multiple business units to develop, update, and improve regulatory affair processes. Assist the strategy implementation and operations for Regulatory Affairs activities, including directing devel...

Senior Regulatory Affairs Specialist

Collabera

Saint Paul, MN

Perform assigned regulatory activities including submissions/responses to country authorities. Daily Responsibilities - suppliers should use: Plan and prepare documents for EU MDR Technical File original submiss...

Regulatory Affairs Manager - Core CRM Sustaining Program Regulatory POC

Boston Scientific

Saint Paul, MN

Oversite management of Core CRMRegulatory AffairsSustaining Program activities, with an emphasis on Leads and Lead accessories product portfolio. Manage a 3-4 person submissions team within a matrixed organization. Lead the CRM...