- Bausch + Lomb (Clearwater, FL)
- …equipment, or process changes before implementation + Collaborate with Quality and Regulatory Affairs to resolve any discrepancies or nonconformances before ... + Knowledge in Sterilization Process (Steam, Radiation and EO). + Strong grasp of global quality and regulatory requirements including cGMP, ISO 13485, and 21… more
- Edwards Lifesciences (Raleigh, NC)
- …for Medicare Services (CMS) and/or Medicare Administrative Contractors (MAC), Medicaid, Veteran Affairs (VA) and commercial payers. **The Director, Global Health ... with experience collaborating cross-functionally with teams such as Sales, Marketing, Clinical, Regulatory , Legal, and Government Affairs to address economic and… more
- Hologic (Newark, DE)
- …the highest quality. Collaborate with top talent across Clinical Development, R&D, Regulatory Affairs , Program Management, Legal, Marketing, and Operations to ... leading major US and global clinical trials across multiple phases of medical device development. You'll ensure studies are executed on-time, on-budget, and with… more
- J&J Family of Companies (Titusville, NJ)
- …Team leadership via matrix interactions includes individuals from TA strategy, GCSO, global regulatory affairs , project management, finance, legal, quality ... and Device Development and Regulation, Program Management, Regulatory Affairs Management, Relationship Building, Safety-Oriented, Scientific Research,… more
- ConvaTec (Lexington, MA)
- …8 to 10 years of clinical trial management experience in conducting and leading global medical device clinical trials, preferably with a sponsor company. + Solid ... understanding of the device development process, ICH guidelines/GCP and specifically, each step...(Study Management, Site Management, Data Management / Data Analytics), Global Head of Clinical Operations, R&D, Regulatory … 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
- Abbott (Santa Clara, CA)
- …stake holders including clinical project management, clinical operations, biostatistics, data management, regulatory affairs , medical affairs as well as ... Abbott is a global healthcare leader that helps people live more...including steering committees, and national principal investigators to support device premarket approval (PMA) applications and premarket notification submissions… more
- Cordis (Miami Lakes, FL)
- …future product launches. + Operate cross-functionally with Commercial, Marketing, R&D, Clinical Affairs , Regulatory , and Quality to align messaging and maintain ... of people and broadening access to life-saving cardiovascular and endovascular technology. As a global leader for over 60 years, we are dedicated to being the heart… more
- Takeda Pharmaceuticals (Boston, MA)
- …communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs , Quality Assurance, Medical Affairs , Marketing, ... knowledge. **Job Description** **Objective:** **Principal responsibilities include:** + Serves as Global Safety Lead (GSL) and the Company-wide patient safety expert… more
- Medtronic (Boston, MA)
- …prioritization. * Collaborate with Verification & Validation, Systems Engineering, and Regulatory Affairs to ensure appropriate test coverage and documentation. ... role, you'll lead a dynamic team, collaborating across departments like R&D, Quality Affairs , and Marketing to spearhead a series of successful RPE project release.… more