- 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
- Medtronic (Washington, DC)
- …similar experience. **NICE TO HAVE** **:** + Experience in counseling on environmental regulatory compliance matters + Experience in counseling on health and ... RoHS, SCIP) + Experience in counseling on US Food and Drug Administration ( FDA ) regulatory requirements + Experience in conducting reviews of advertising and… more
- University of Michigan (Ann Arbor, MI)
- HLD & Regulatory Compliance Manager Apply Now **Job Summary** The High-Level Disinfection (HLD) and Regulatory Compliance Manager oversees fiscal ... not limited to The Joint Commission, CDC, OSHA, CMS, FDA , AORN and AAMI. Ensures continual accreditation readiness with...Detail** **Job Opening ID** 256715 **Working Title** HLD & Regulatory Compliance Manager **Job Title**… more
- Owens & Minor (Indianapolis, IN)
- … and provides day to day oversight of clinical regulatory compliance including but not limited to FDA regulations, accreditation standards, state ... + Assists in the interpretation and understanding of federal and state regulatory compliance in the field as they apply to the company's standard operating… more
- Houston Methodist (Houston, TX)
- …**SERVICE ESSENTIAL FUNCTIONS** + Ensures compliance of general and study-specific regulatory and/or safety-related processes with SOP's, FDA , GCP, NIH and ... At Houston Methodist, the Regulatory Compliance Specialist position is responsible...sponsor's regulatory team. This position communicates with regulatory affairs office for FDA submissions across… more
- University of Michigan (Ann Arbor, MI)
- …**Job Detail** **Job Opening ID** 257783 **Working Title** Regulatory Project Manager **Job Title** Research Compliance Spec Sr **Work Location** Ann Arbor ... Regulatory Project Manager Apply Now **How...or medical device to ensure clinical research excellence and regulatory compliance , as set forth by the… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** As the Audit Program Manager , you will manage Quality Audit Programs including development, scheduling, and implementing plans for ... previous quality audits and external inspections, industry trends and the external regulatory environment. **Job Description** We are **the makers of possible** BD… 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
- Mount Sinai Health System (New York, NY)
- …will be responsible for supporting the regulatory affairs team to ensure compliance with FDA regulations, ICH-GCP guidelines, and other relevant local and ... directly to the Medicine Clinical Trials Office (MCTO Research Manager to assist with the management of the electronic...vital for ensuring the integrity of clinical trials, maintaining regulatory compliance and contributing to the overall… 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
- Takeda Pharmaceuticals (Boston, MA)
- …global regulatory strategy is updated and executed, ensuring global regulatory compliance . + May communicate with FDA as required. + Ensures project team ... in order to bring life-changing therapies to patients worldwide. Join Takeda as a Manager , Global Regulatory Lead Oncology where you will contribute to global … more
- Colgate-Palmolive (Piscataway, NJ)
- …adherence to applicable US FDA and Health Canada regulations. * Manage regulatory activities to ensure compliance with FDA 's Modernization of Cosmetic ... goals. Together, let's build a brighter, healthier future for all. **Scope:** The Regulatory Affairs Associate Manager supports Colgate's Oral Care and Personal… 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
- Imperative Care (Campbell, CA)
- Title: Sr Manager Regulatory Affairs This position is...projects to remain in compliance with all FDA and other US and international regulatory ... will oversee the day-to-day activities for a team of Regulatory Affairs Specialists. An individual in this role will...Document Change Order requests, CAPAs, NCRs, etc. + Ensure compliance with FDA and OUS regulations and… 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
- AbbVie (Irvine, CA)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs US Advertising and Promotion - Neuroscience, ... professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence… more
- Medtronic (Minneapolis, MN)
- …more connected, compassionate world. **A Day in the Life** As the Regulatory Affairs Strategic Planning Program Manager specializing in developing Globalization ... affairs and other departments to ensure alignment on regulatory globalization execution and compliance activities. +...from inception to completion + In-depth knowledge of global regulatory requirements ( FDA , EMA, CFDA, PMDA, etc.)… 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
- Colgate-Palmolive (Topeka, KS)
- …of Hill's products in compliance with US and global regulations. As the Manager , Regulatory Affairs (Pre-Market), you will ensure Hill's products meet all ... and strategies. + Stay informed on international developments affecting US regulatory compliance and manufacturing. **Building Relationships and Advocacy:** +… 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) || ... entity other than @Olympus.com, it is likely not legitimate._ **Job Description** The Regulatory Affairs (RA) Program Manager Digital Strategy is responsible for… more
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