- Abbott (Plymouth, MN)
- …strategies with the help of international regulatory affiliates. + Compile, prepare, review and submit medical device submissions to regulatory agencies ... preferably in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, etc. + Minimum 2 yrs. regulatory experience and… more
- System One (Florham Park, NJ)
- …adherence to timelines, and the quality of submissions + The Executive Director, Regulatory Affairs will review and approve completed work. Benefits System One ... Job Title: AD or Director, Regulatory Affairs Strategy Location: Florham Park, NJ (10...IND applications and 1 NDA) + Knowledge of and Compliance with FDA, EMEA, PMDA guidances + Performance will… more
- Terumo Neuro (Aliso Viejo, CA)
- …lines per MicroVention procedures. + Review promotional material and labeling for regulatory compliance as assigned. + Develop and maintain regulatory ... for worldwide product approval submission activities focused on US/EU/Canada and ensuring compliance to FDA and international regulatory agency requirements for… more
- Cedars-Sinai (Los Angeles, CA)
- …range of questions. Generates reports and maintains files and documentation for compliance with regulatory requirements (federal and local agencies, including ... Duties and Responsibilities:** + Submits continuations and amendments to ensure compliance with regulatory requirements and institutional polices. + Completes… more
- Sumitomo Pharma (Providence, RI)
- …product portfolio. + Serve as the resident senior expert on all regulatory matters with key external stakeholders, internal steering/ review committees, business ... communication + Ensure that development of launch materials/new claims with Marketing, Medical and Legal are guided by applicable regulatory requirements +… more
- TEKsystems (Nashville, TN)
- Regulatory Compliance Project Specialist - 100% Remote Category: Regulatory Affairs | Location: Remote Type: Full-Time, Multi-Year Project Join a High-Impact ... of America's Largest Carriers TEK GS is hiring a Regulatory Compliance Project Specialist to support Verizon's...and manage FUZE SPM tasks for construction approval. + Review and validate construction documents (1A/2C surveys, FAA filings,… more
- BD (Becton, Dickinson and Company) (Salt Lake City, UT)
- …on submissions and other issues + Independently reviews product changes to ensure regulatory compliance , including assessment of impact to US and CE Mark ... position independently supports projects to bring new and modified medical devices to market and ensure ongoing compliance...and other regulatory documents for submission to regulatory bodies for product review and approval… more
- Ascendis Pharma (Princeton, NJ)
- …medical , payor, corporate, and other non-promotional materials to assess for regulatory compliance with the applicable regulations, guidance documents, and ... one team to achieve extraordinary results. The Associate Director Regulatory Affairs, Advertising and Promotion will be an internal...internal policies/best practices + Collaborate with Medical , Legal, Commercial, and Compliance to execute… more
- Actalent (Piscataway, NJ)
- …Manager to lead our team in managing lab documentation and ensuring global regulatory compliance . This role involves overseeing a fast-paced, high-volume lab ... Complete all necessary training and certifications. + Support with sample handling and regulatory compliance . Essential Skills + Bachelor's Degree in Biology or… more
- Colgate-Palmolive (Topeka, KS)
- …Ownership and Resolution:** Act as the Subject Matter Expert (SME), driving regulatory compliance and issue identification/resolution across a designated phase ... inform critical decisions. This role includes leading the preparation, review , and management of all required regulatory ... Points of View (POVs) to ensure standardization and compliance across regulatory processes. The Specialist will… more