- 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 ... medical devices. This leadership role leads an OSTA Core Regulatory Affairs Team and provides world-class ...Manager to plan and direct the OSTA Core Regulatory Affairs Team activities including but not… 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
- 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
- Chiesi (Boston, MA)
- …Promotional Material/External Communications Responsibilities: + Work in the Global Rare Diseases, Regulatory Affairs Ad Promo function for the United States, ... departments to ensure product risks are appropriately communicated. + Provide training to Regulatory Affairs and other departments as appropriate. + Review and… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory Strategy, Manufacturing facilities,… 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
- 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
- Parexel (Boston, MA)
- …* Work on impactful global programs that directly support patient safety and regulatory compliance. * Collaborate with a diverse, international team across ... Join us as a **Global Labeling Operations Manager ** , where you'll work alongside a large,...AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering accurate,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …(https://www.olympusamerica.com/careers) . **Job Description** The Global Lead Medical Affairs - Gastroenterology (GLMAG) is a board-certified, fellowship trained ... proficient in endoscopy with deep clinical practice knowledge, medical affairs industry experience, and/or health leadership competencies and management… more
- Dana-Farber Cancer Institute (Boston, MA)
- …in the clinical research field is preferred. + Experience in knowledge of regulatory affairs , research ethics, and Responsible Conduct of Research (RCR) is ... of translational research principles and biobanking processes. + Basic knowledge of regulatory affairs , research ethics, and responsible conduct of research +… more