Principal Regulatory Affairs Specialist jobs

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PRINCIPAL REGULATORY AFFAIRS SPECIALIST (MEDLANCE.CO)

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...

CompanyMedlance
AddressRemote
CategoryEducation/Training
Salary$30 - $300 an hour
Job typeContract
Date Posted 2 months ago See detail

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...

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

Johnson & Johnson

Danvers, MA

...

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...

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...

Senior Product Stewardship & Regulatory Affairs Specialist Job

Arkema

United, PA

Prepare and maintain commercial and R&D composition databases, SDSs and labels, packaging requirements, certificates of compliance (Kosher, FDA, RoHS etc.), product registrations and approvals (including FIFRA, NSF, UL, etc.), for...

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...

Sr. Regulatory Affairs Specialist (Andover or Mansfield, MA)

Smith & Nephew

Andover, MA

$115,000 - $130,000 a year

Coordinates associated registration or submissions leading to market clearance/approval. Provide regulatory direction to project teams for product development/design control related activities. Drafting, authoring and submitting P...

Senior Specialist Regulatory Affairs - Nutrition - Lake County , IL or Columbus, OH

Abbott Laboratories

Lake Forest, IL

$72,700 - $145,300 a year

Training and career development, with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives, and retirement plans Health care and well-being programs including...

Regulatory Affairs Specialist - Labeling

Nesco Resource

Andover, MA

Up to $38.46 •

Maintains current knowledge of the development and changes to applicable laws, regulations and industry standards for global markets, providing guidance in interpreting regulations and agency guidelines.. Initiates, reviews and a...

USA Regulatory Affairs Specialist Project Lead I Scientific

Adecco

Bridgewater, NJ

$ 88 - $ 89.22 / Hour

Adecco Medical & Science is hiring a remote contract Regulatory Affairs Team Lead for our Pharmaceutical partner based out of Bridgewater, NJ.The anticipated wage for this position is between $88 and $89.22. A possible meeting in...

Sr Regulatory Affairs Specialist

Johnson & Johnson

Irvine, CA

...

Regulatory Affairs Specialist I

Fresenius Kabi Ag

Lake Zurich, IL

Collaborate with local and international colleagues to generate high quality submissions to obtain drug and/or medical device approvals in target markets. Gather design and development information on products from cross-functional...

Regulatory Affairs Specialist

Argen Corporation

San Diego, CA

Argen is a global leader in dental manufacturing with headquarters in San Diego, CA, subsidiaries in Canada, Germany, UK, and China, and sales in 105 countries worldwide. Our Awesome Benefits!Working for a growing innovative compa...

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 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 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...

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...

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...

Specialist - Regulatory Affairs

Biospace

Plainsboro, NJ

Therapeutic Area:. Assist Manager/Director in review of labeling for marketed products and new products as assigned. Maintain up-to-date knowledge of data requirements and formats, applicable current SOPs, regulations, and guideli...