- Vanderbilt University Medical Center (Nashville, TN)
- …all requirements. . The VUMC Laboratory Quality Management Department is in need of an FDA Regulatory Affairs Manager to join the team! **This position is ... **Organization:** Director's Administration **Job Summary:** Leads VML's responses to the recent FDA LDT regulations. Develops a team to support our LDT efforts and… more
- Olympus Corporation of the Americas (Westborough, MA)
- …position leads cross-functional team to investigate and develop responses to Quality/ Regulatory compliance communications. Authors, leads and manages all ... Quality/ Regulatory compliance communications to ensure compliance of the...your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). Posting Notes:… more
- Houston Methodist (Houston, TX)
- …and safety reporting regulations, processes, and procedures under the direct supervision of the Regulatory Compliance Manager (serves as a resource for ... study specific processes under the direct supervision of the Regulatory Compliance Manager **QUALITY/SAFETY ESSENTIAL...+ Ensures compliance of general and study-specific regulatory and/or safety-related processes with SOP's, FDA ,… more
- Lundbeck (Deerfield, IL)
- …of product documentation intended for regulatory submissions for accuracy and compliance with FDA regulations. Manages, reviews and represents US ... Senior Manager Regulatory Strategy - Remote Opportunity...meetings. Identifies risk, problem-solves, and offers solutions. Manages/supports related FDA submission activities in compliance with current… more
- Unilever (San Francisco, CA)
- THE ROLE: REGULATORY AFFAIRS MANAGER You are a compliance expert with roots in the supplement industry and have a passion for supporting the innovation of ... cross-functionally and provide regulatory expertise to ensure compliance with applicable FDA and FTC regulations....Francisco or Los Angeles, CA HOURS: Full-time, Exempt MANAGER : Regulatory Affairs Director … more
- AbbVie (Irvine, CA)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Sr Manager Regulatory Affairs represents regulatory affairs for device ... primarily for US/EU regulatory filings, ensures technical accuracy, and regulatory compliance . Ensures that applications are executed appropriately and… more
- Cardinal Health (Columbus, OH)
- …and internal standards. + ** Regulatory Compliance ** + Ensure ongoing compliance with applicable regulations (eg, FDA , EMA, ICH, GxP) throughout the life ... including INDs, NDAs, BLAs, CTAs, and other filings to regulatory authorities ( FDA , EMA, etc.). + Manage...legal, medical writing, nonclinical, and quality teams to ensure regulatory compliance in clinical trial execution and… more
- Olympus Corporation of the Americas (Westborough, MA)
- …If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || ... + Guides/Coaches the cross functional team focusing on communication with regulatory agencies regarding compliance issues. + Guides/Coaches SMEs against… more
- Takeda Pharmaceuticals (Lexington, MA)
- …least one complex product or therapeutic area/multiple products to help ensure regulatory compliance of promotional materials generated for assigned US products ... is true to the best of my knowledge. **Job Description** **Senior Manager , US Medical Ad/Promo Regulatory Review** **Takeda Pharmaceutical** **Lexington, MA… more
- BeiGene (Emeryville, CA)
- …Ensure regulatory submissions are maintained in compliance with regulatory requirements. + Address device inquiries from FDA /HAs, IRBs/sites, and ... **General Description:** The Senior Manager , Regulatory Diagnostics will lead the...as required. **Knowledge & Skills:** * Working knowledge of FDA and ICH regulatory guidance and regulations.… more
- System One (Lakewood, CO)
- Job Title: Manager , Regulatory Affairs Location: Lakewood, CO - Hybrid Salary: $125,900 - $157,400 + 15% bonus Job Summary: The Manager , Regulatory ... lead and guide a high-performing Regulatory Affairs team, ensuring compliance with domestic and international regulations while driving strategic regulatory … more
- Amgen (Washington, DC)
- …do** Let's do this. Let's change the world. The Regulatory Affairs Senior Manager at Amgen ensures the company's compliance with all regulations and laws ... time for a career you can be proud of. ** Regulatory Affairs Senior Manager - Regional ...of interactions with regulatory agencies + Ensure regulatory product compliance for product (eg IMR,… more
- Stanford Health Care (Palo Alto, CA)
- …staff, clinic managers, nurse managers, etc.) on medication-related issues such as regulatory changes/ compliance , FDA drug recalls, drug information, sample ... Managers and clinic staff on pharmacy-related issues such as regulatory changes/ compliance , FDA drug recalls,...storage areas on-site and remote sites. + Responds to manager inquiries related to compliance issues. **Education… more
- AbbVie (North Chicago, IL)
- …execution of the regulatory strategy. 7. Serve as HA liaison with FDA for routine communications in support of filings including complete & timely responses ... internal cross-functional team who may contribute to regulated communication on Regulatory / FDA issues including Public Affairs, Clinical Development, Legal, &… more
- Abbott (Alameda, CA)
- …submission and approval requirements. + Participate in risk benefit analysis for regulatory compliance . + Monitor impact of changing regulations on submission ... their glucose levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager - Digital Health Technology** will work on-site… more
- University of Washington (Seattle, WA)
- …Research Program and will be instrumental in providing oversight of all research regulatory compliance . This position will not only impact these research ... This position provides significant contributions to research development, implementation and regulatory compliance for the Division of Medical Oncology. The… more
- Fortive Corporation (Everett, WA)
- **About the Job** The Regulatory Affairs and Quality Assurance Manager will provide Quality Management, Regulatory and Quality Engineering expertise, ... to drive continuous improvement in support of quality and compliance objectives. This position reports to the Global RA/QA...efforts, including, but not limited to: + Support for regulatory meetings with FDA . + External health… more
- Simplot (Boise, ID)
- Regulatory Manager , Simplot Global Food - Boise, ID Location: Boise, ID, US, 83702-6924 The JR Simplot Company is a diverse, privately held global food and ... labeling guidelines. Support Marketing, Sales, Quality Assurance, Purchasing and Operations on regulatory and compliance related labeling issues. Keep abreast of… more
- MD Anderson Cancer Center (Houston, TX)
- The primary purpose of the Manager , Clinical Protocol Administration position is to collaborate with the research team and Principal Investigator (PI) to coordinate ... clinical trial quality assurance, submission and regulatory process for the departmental. To evaluate and prioritize clinical trial inspection readiness. To provide… more
- Highmark Health (Pittsburgh, PA)
- …and coordinate all activities related to maintaining an ongoing state of regulatory compliance through proactive risk assessments and mitigation efforts. Manage ... risk or deficiency; oversee ongoing monitoring to ensure sustained regulatory compliance . (20%) + Support and participate...Commission, The PA Department of Health, OSHA, and the FDA . In this role, represent the hospital during surveys… more