- Olympus Corporation of the Americas (Westborough, MA)
- …technologies aligned with the Business Unit priority. + Interface with International Regulatory Affairs Team to ensure global planning considerations ... + Minimum of 10 years of Regulatory Affairs experience, ideally within the medical device ... Device . + Demonstrated leadership in managing the global submission process for regulatory approvals across… more
- Olympus Corporation of the Americas (Westborough, MA)
- …in engineering or life sciences required. + Minimum of 7 years prior regulatory affairs experience in the medical device industry, or a minimum of 5 years ... more about Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** The Sr. Regulatory Affairs (RA) Specialist II Digital Health supports … more
- Olympus Corporation of the Americas (Westborough, MA)
- …BS or comparable required. + Minimum of 10 years' experience in Regulatory Affairs , ideally within the medical device or digital health industries. + Minimum ... of a high-growth, innovative team, this position oversees collaboration between internal Olympus Regulatory Affairs Teams and external vendors as needed and will… more
- Olympus Corporation of the Americas (Westborough, MA)
- …between Sales and Marketing, R&D, PMO, HEMA, Risk Management, Quality and Regulatory Affairs , and investigational sites. + Ensures clinical studies are ... conducted in compliance with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards. + Other… more
- Olympus Corporation of the Americas (Westborough, MA)
- …conducted in compliance with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards. + Other ... industry experience post-degree preferably in Clinical Research, Clinical Development or Medical Affairs within the medical device industry. + Minimum of 5… more
- Olympus Corporation of the Americas (Westborough, MA)
- …and governance supports business objectives through: proactive monitoring and application of global regulatory requirements within the regional QMS; leading the ... improve Olympus compliance profile. + Monitors plans and applies Global regulatory or Olympus requirements into the...Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs … more
- Sanofi Group (Framingham, MA)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the ... could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Learn more about Life at Olympus (https://www.olympusamerica.com/careers) . **Job Description** The Global Lead Medical Affairs - Gastroenterology (GLMAG) is a ... (peer-to-peer) as well as societal engagement. + Clinical Research: To support the Global Head of Clinical Affairs in the conception, development, and… more
- Hologic (Marlborough, MA)
- …Services globally. You will collaborate with key stakeholders, including Regulatory Affairs , Quality Assurance, Supplier Quality Assurance, Engineering ... Solutions Analyst, Global IT Quality Solutions** to join our **Quality, Regulatory , and Product Life Cycle Management Systems Center of Excellence (COE)** . This… more
- Candela Corporation (Marlborough, MA)
- …quality / regulatory / compliance. . Working understanding of relevant global /regional medical device regulations and standards with particular emphasis on ... improvement actions related feedback. . Jointly accountable with Quality System (QS) and Regulatory Affairs (RA) Leadership for ensuring the QS is effectively… more
- Hologic (Marlborough, MA)
- …product lifecycle. As a subject matter expert, you will partner with R&D, Regulatory Affairs , and Manufacturing Engineering teams to embed quality and compliance ... planning, and requirements traceability. + Familiarity with Good Laboratory Practices and global regulatory requirements for medical devices. + Proficiency in… more
- Hologic (Marlborough, MA)
- …role in new product development, ensuring that design controls, risk management, and global regulatory compliance are maintained from concept to product launch. ... compliance. + Collaborative and team-oriented, building strong relationships across R&D, Regulatory Affairs , Manufacturing, and other key stakeholders. +… more
