- AbbVie (Irvine, CA)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager , Regulatory Affairs , Device works ... Develops, implements, and documents policies and procedures within the regulatory affairs department. Participates in initiatives internal to RA Device. To… more
- Olympus Corporation of the Americas (Westborough, MA)
- …the Global Senior Manager to plan and direct the OSTA Core Regulatory Affairs Team activities including but not limited to analysis of requirements and ... and relevant consumer protection laws). + Oversee and support regulatory submissions and compliance filings where applicable...|| United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/ RA… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- **Job Description Summary** The Senior Regulatory Affairs ( RA ) Specialist within the BD Interventional Surgical Devices Business unit will work on ... Under the mentorship of the Sr. RA Manager of Regulatory Affairs , they...medical devices in the US The Senior RA Specialist will also support related regulatory … more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... CMC requirements. + Plan, prepare, and review CMC sections of regulatory submissions (IND/IMPD/NDA/MAA, post-approval supplements). Determine regulatory … more
- Olympus Corporation of the Americas (Westborough, MA)
- …more about Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** The Sr. Regulatory Affairs ( RA ) Specialist II Digital Health ... teams for sustaining products to provide input on global regulatory requirements. + Support regulatory submissions...|| United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/ RA… more
- Stryker (Mahwah, NJ)
- ** Senior Manager , Regulatory Affairs - Joint Replacement Division** **Location:** Hybrid - Mahwah, NJ As the ** Senior Manager , Regulatory ... new product launches and patient-specific solutions. You will work across the Regulatory Affairs teams and cross-functional partners with global locations, time… more
- Philips (Plymouth, MN)
- …of the Regulatory Affairs ( RA ) Manager or a more senior Regulatory Affairs Specialist, a Regulatory Affairs Intern is responsible ... department project with direct support from management or more senior regulatory affairs specialists. Under...updates/ submissions . + Support more senior RA Specialists in the preparation of regulatory … more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA). - RAC ... and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
- Dentsply Sirona (Milford, DE)
- …channels, enhancing business relationships. + Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited to ... and other regulated products globally. + Leads and manages regulatory submissions , including 510(k) submissions ,...degree in a relevant field, such as life sciences, regulatory affairs , or a related discipline. +… more
- Medtronic (Santa Rosa, CA)
- …position will be based in Mounds View, MN or Santa Rosa, CA. The ** Senior ** ** Regulatory Affairs Specialist** will support our innovative Transcatheter ... submissions and negotiates their approval with the agencies. The Sr Regulatory Affairs Specialist is responsible for assessment of device changes for… more