- Abbott (Santa Clara, CA)
- …device business units that Leveraged Services team supports. **The Opportunity** The **Senior Manager Regulatory Affairs** will work for our Global Regulatory ... units that Leverage Services team supports, including the execution of strategic regulatory initiatives, regulatory submissions , agency relationship and… more
- Sumitomo Pharma (Lincoln, NE)
- …agencies. + Understands evolving Health Authority (HA) standards and procedures for regulatory submissions . Guides and trains project teams on new requirements, ... a dynamic, highly motivated, and experienced individual for the position of Senior Manager , Regulatory Operations, For assigned projects, the Senior Manager … more
- Olympus Corporation of the Americas (Westborough, MA)
- …about Life at Olympus (https://www.olympusamerica.com/careers) . **Job Description** Assist the Manager , Regulatory Affairs in obtaining approval to market ... for Canadian Class 2, 3 or 4 Device License submissions . + Lead development of responses to regulatory...ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). **Let's realize your potential, together.**… more
- Abbott (St. Paul, MN)
- …Additionally, will coordinate preparation of well organized, complete and scientifically sound regulatory submissions as well as interface directly with various ... vessel closure devices and peripheral stents. **The Opportunity** This ** Regulatory Affairs Project Manager ** position is an...project management skills to plan for, lead and author regulatory submissions in key markets (including US… more
- AbbVie (Waltham, MA)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works ... enable first pass approvals. Develops and manages content strategy for regulatory submissions , including INDs/CTAs and amendments, new marketing applications… more
- Abbott (Alameda, CA)
- …recognized as an expert and resource within the department, leading successful regulatory submissions and interactions with regulatory agencies while ... levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager ** will work on-site in...related discipline + Previous experience with Class III IDE submissions and/or PMA submissions or EU Technical… more
- Bausch Health (Bothell, WA)
- …itwhere your skills and values drive our collective progress and impact. The Manager Regulatory Affairs provides direct support to Solta operations for their ... for post-market surveillance, including annual reports, and other required documents. Regulatory Submissions and Documentation + Manage the preparation,… more
- Otsuka America Pharmaceutical Inc. (Bismarck, ND)
- …pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA). - RAC ... planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with… more
- Abbott (Alameda, CA)
- …as industry trends and trains staff regarding changing regulations that affect regulatory submissions . Maintains knowledge of current and pending regulations ... levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager - International Compliance Operations**...of those years related to the preparation of FDA submissions (PMA, IDE, 510(k)) for Class I, II, and… more
- Grifols Shared Services North America, Inc (Fort Worth, TX)
- …the scope of experimentation and the selection of data needed to support regulatory submissions . + Interacts with regulatory authorities regarding programs ... and development of contingency plans. + Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements… more