- Olympus Corporation of the Americas (Westborough, MA)
- …and connected technologies aligned with the Business Unit priority. + Interface with International Regulatory Affairs Team to ensure global planning ... traditional medical devices. This leadership role leads an OSTA Core Regulatory Affairs Team and provides world-class regulatory strategies for digital… more
- Olympus Corporation of the Americas (Westborough, MA)
- …responses to regulatory or auditor inquiries as directed. + Interface with International Regulatory Affairs Team and drive preparation of dossiers for ... Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** The Sr. Regulatory Affairs (RA) Specialist II Digital Health...registration on for other international markets such as Japan, Middle East and Africa,… more
- Carrier (Beverly, MA)
- …manage submissions and regulatory changes, and support product launches across international markets. The ** Regulatory Affairs & Compliance Lead** ... to innovation, sustainability, and global impact. **About this role** As the ** Regulatory Affairs & Compliance Lead** at **Sensitech** , you will be the … more
- J&J Family of Companies (Raynham, MA)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... We are searching for the best talent for a ** Regulatory Affairs Specialist II** to support our...licenses and authorizations for the maintenance of existing products, international registrations, and dossiers, including, but not limited to… more
- Sumitomo Pharma (Boston, MA)
- …dynamic, highly motivated, and experienced leader for the position of **Vice President, Regulatory Affairs Oncology** . The candidate must be deeply experienced ... of IND and NDA submissions, FDA and other global regulatory interactions, as well as international submissions....to VP Clin Dev and CMO + Manage Commercial Regulatory Affairs function and serve as an… more
- GRAIL (Boston, MA)
- …products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... regulatory approval. + Monitor and report on international regulatory developments and LDT requirements that...of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties… more
- Cardinal Health (Boston, MA)
- **_What Regulatory Affairs contributes to Cardinal Health_** Regulatory provides regulatory affairs and product development consulting services to ... submissions as well as clinical research and manufacturing process consulting. Regulatory Affairs plans, coordinates and implements regulatory strategies… more
- Dentsply Sirona (Waltham, MA)
- …business relationships. + Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, ... degree in a relevant field, such as life sciences, regulatory affairs , or a related discipline. +... projects. + In-depth knowledge of FDA 510(k) and international regulations (eg, EN ISO 13485, EU MDR). +… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is ... medicine promotion. **How you will contribute:** + As our Associate Director, Global Regulatory Affairs Advertising and Promotion lead you will act as the… more
- Olympus Corporation of the Americas (Westborough, MA)
- …of a high-growth, innovative team, this position oversees collaboration between internal Olympus Regulatory Affairs Teams and external vendors as needed and will ... comparable required. + Minimum of 10 years' experience in Regulatory Affairs , ideally within the medical device...Experience with 510(k), De Novo submissions, CE marking, and international regulatory pathways for Software as a… more