- Medtronic (North Haven, CT)
- …for this opening will close on - 30 Dec 2025 **Position Description:** Sr. Regulatory Affairs Specialist for Covidien, LP (a Medtronic company) located ... field and four (4) years of experience as a Regulatory Affairs Specialist or related...Class III medical devices, including pre-clinical, clinical, approval, and post -approval with MDR implementation; MDR Regulation (EU) 2017/745, and… more
- Edwards Lifesciences (Hartford, CT)
- …Director and will collaborate with multiple departments including Sales, Clinical Affairs , Marketing, Quality, Regulatory , and Education. After extensive ... the world. As a part of the Field Clinical Specialist team, you will be a critical part of...the areas of valve crimping, case management, pre-case planning, post -case management, 3 Mensio management, Therapy Awareness program management… more
- Boehringer Ingelheim (Ridgefield, CT)
- …of required trial documents, contracts and necessary approvals + All Regulatory Requirements are satisfied prior to trial/site initiation + Where necessary, ... for CRAs, investigators and site staff + In collaboration with Trial Resource Specialist and with support from CRAs as appropriate, ensures collection of required… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Legal, Epidemiology & RWE, early and late-stage Clinical Development teams, Regulatory Affairs , Drug Safety, Digital). **Eligibility Requirements** : + ... from launch through lifecycle. + Acts as Team Member Medical Affairs (TMMA) and collaborates cross-functionally (Clinical Development, Regulatory , Safety,… more
- Boehringer Ingelheim (Ridgefield, CT)
- …global functions (eg Epidemiology, early and late-stage Clinical Development teams, Regulatory Affairs , Drug Safety, Marketing, PPSS (Product Pipeline Scientific ... the roll-out of scientific and study data pre- and post -launch. + Takes product-specific responsibility for Phase IV trial...product specific input to global Pharmacovigilance (PV) and global Regulatory Affairs (RA). + Develops and/or provides… more
- Boehringer Ingelheim (Ridgefield, CT)
- …and facilitation skills. + Strong track record of interactions with regulatory affairs authority, international societies and other relevant stakeholders. ... Concept studies), ideally clinical specialization hematology, oncology or organ specialist . Solid relationships with key stakeholders. + Sound medical...Must be willing to take a drug test and post -offer physical (if required). + Must be 18 years… more