Regulatory affairs jobs in Cambridge, MA

Qualifications. degree or above in a relevant discipline required years of industrial experience in IVD or medical device FDA registration in Chinese preferred Tasks. and support n..

Ensure all relevant deliverables including investigator brochures, publications, all regulatory.. Lead statistical programming activities for regulatory submissions following CDISC standards. Review key..

Pharvaris is the place for you. We are now looking for a highly driven Manager, Regulatory Affairs to.. years' experience in drug development, 2. in Regulatory Affairs. Knowledge of regulatory drug..

This position handles complaint investigations which includes investigations at Azurity and CDMOs, coordination with medical affairs, trending complaints, escalation to FDA. Person also needs to..

Regulatory Affairs Consultant Cambridge MA, Remote with occasional site time Medical Device 6 month.. The Role. You will play a key role in ensuring compliance with the regulatory requirements and standards..

Collaborate with internal cross functional teams of experts including Product, Engineering, Regulatory, Quality, Security, Compliance, and Customer Service Manage project tasks to ensure..

Support Quality Management by facilitating regulatory agency inspections and related activities.. Experience developing SOPs and Work Instructions, reviewing internal clinical, regulatory, biometric..

Drive conclusions and develop next steps Work closely with Regulatory Affairs, and other cross.. Use in depth knowledge of Pharmacovigilance science and Regulatory Guidance to provide expertise and..

At this level, the incumbent independently manages a major segment of the Company's regulatory effort.. Contributes to multidisciplinary teams on the regulatory strategy for drug development including CMC..

Job Description About the Job The Regulatory Affairs (RA) Director is responsible for the development.. This role is responsible for international regulatory strategy, including registration of new products..

Senior Regulatory Affairs Manager (U.S. Hub based location) The Senior Regulatory Affairs Manager will.. You will manage a Regulatory Affairs team supporting various new and sustaining programs for Philips..

Lead the regulatory efforts for IND enabling activities, including the preparation of the.. Spearhead the development of a future regulatory affairs team, providing mentorship and guidance to team..