- 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
- 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
- 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
- Henkel (Stamford, CT)
- …Stamford, CT, Henkel Consumer Brands **Quality Manager , Internal Manufacturing and Regulatory Compliance ** At Henkel, you can build on a strong legacy ... taken and effective. + Supports delivery and training on quality standards and FDA GMP requirements. + On-site plant trial and zero production support. + Supports… 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
- Abbott (Santa Clara, CA)
- …results for millions of people. **What You'll Work On** We are recruiting for a SENIOR MANAGER REGULATORY AFFAIRS to join the Regulatory team at the Santa ... responsible for coordinating, planning, preparation, assembly, and review of regulatory strategies and submissions to the FDA ,... compliance with company policies and procedures (eg compliance with FDA , BSI, EEO regulations, etc.).… more
- Takeda Pharmaceuticals (Exton, PA)
- …least one complex product or therapeutic area/multiple products to help ensure regulatory compliance of promotional materials generated for assigned US products ... best of my knowledge. **Job Description** About the role: Join Takeda as a Senior Manager , US Medical Ad/Promo Regulatory Review where you will serve as an… 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
- 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
- Actalent (Cincinnati, OH)
- Quality & Regulatory Affairs Manager Job Description The Manager of Quality and Regulatory Affairs will work directly with internal and external teams to ... Label Project, USDA Organic), performance, safety/toxicity, micro, human testing, retail compliance , etc. + Manage regulatory -related licenses and registration… more
- Amgen (Los Angeles, CA)
- …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
- Actalent (Cincinnati, OH)
- … with regulations, including tracking and substantiating any claims made. + Regulatory Compliance : Ensure all products comply with relevant federal and ... Overview: The Manager of Quality and Regulatory Affairs...and compliance documentation as needed. + Online Compliance : Oversee the accurate posting of key regulatory… 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
- Takeda Pharmaceuticals (Boston, MA)
- …maintenance of plasma derived therapies, while ensuring compliance with applicable regulatory requirements. + Liaises with the US FDA on submissions within ... therapies for patients with immunologic, hematologic, and other complex diseases. As Manager Regulatory Lead you will be accountable for recommending and… more
- AbbVie (North Chicago, IL)
- …products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in ... Advise internal customers who may contribute to regulated communication on Regulatory / FDA issues including Public Affairs, Clinical Development, Legal, 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
- Actalent (Kent, WA)
- Job Title: Regulatory Compliance TechnicianJob Description The Regulatory Compliance Technician will be responsible for researching and adhering to ... FDA labeling and compliance laws. This role...finished product packaging with both internal specifications and external regulatory requirements. The Regulatory Compliance … 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
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