- J&J Family of Companies (Santa Clara, CA)
- … regulatory submissions by analyzing data, interpreting requirements, and supporting the Regulatory Affairs team to ensure compliance with FDA, EU MDR, and ... teams to reach risk-based decisions in complex capital medical device product reviews. + Uses analytical skills and innovative...audits, and MDSAP assessments, with a strong understanding of global regulatory requirements. + Proficiency in 21… more
- Stryker (Fremont, CA)
- …do:** **Technical Responsibilities:** + Works with Divisional Leadership, KOLs, Marketing, Clinical Affairs and Regulatory Affairs and regional organizations ... vetting with all internal stakeholders. + Works with Divisional Leadership, Marketing, Clinical Affairs and Regulatory Affairs and regional organizations to… more
- Genentech (South San Francisco, CA)
- …role will primarily support Research and Early Development, Clinical Operations, Global Product Development, and Medical Affairs functions by providing ... highly experienced R&D attorney for life sciences/biotech clients, with deep experience in regulatory law related to early and late stage research and development of… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …by closely working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs , Marketing, Market Access, Medical Affairs , Drug ... effectively with colleagues in Supply Chain, Accounting, Market Access, Quality Assurance, Regulatory Affairs , Finance, etc. of Mitsubishi Tanabe Pharma Group,… more
- PCI Pharma Services (Rockford, IL)
- …+ Collaborate with cross-functional teams, including Manufacturing, Quality, Engineering, and Regulatory Affairs . + Review and approve equipment specifications, ... Life changing therapies. Global impact. Bridge to thousands of biopharma companies...of PCI. **Job Title: Senior Validation Engineer - Medical Device Assembly (CDMO)** **Location:** [Rockford] **Department:** Quality **Reports To:**… more
- Roche (Indianapolis, IN)
- …Directive/InVitro Device Requirements (IVDD/IVDR), European Union Conformity (CE), other global , regulatory , and legal guidelines. + coordination of the ... In close collaboration with our interfaces in Marketing, R&D, Regulatory Affairs and IT, we ensure that...**Knowledge, Skills & Preferences** + Prior experience in medical device , pharmaceutical or related industries is preferred. + You… more
- DEKA Research & Development (Manchester, NH)
- …minimize time to market + Insure the organization stays up to date on global regulatory changes to medical device biocompatibility standards and requirements ... Senior Scientist to join our team focused on medical device and combination product development. The individual in this...this role will work directly with Research & Development, Regulatory & Clinical Affairs and Quality Engineering… more
- Organon & Co. (Jersey City, NJ)
- …cross-functional interactions with early clinical development, late-clinical development, regulatory affairs , safety and pharmacovigilance, Chemistry, ... Manufacturing and Controls (CMC), medical affairs and business development are critical to the success...to inform mitigation strategies in accordance with regional and/or global regulatory requirements. + Actively participate in… more
- Molnlycke Health Care (Atlanta, GA)
- …us. We're seeking a Director, Americas Commercial QARA to lead our regional Quality and Regulatory Affairs strategy across the Americas . This role is part of ... improve local quality management systems and ensure alignment with global processes. + Direct liaison with regulatory ...+ Minimum of 10 years in an international medical device company, with at least 5 years in a… more
- Cordis (New York, NY)
- …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 ... treatments for coronary and peripheral artery diseases. With four Investigational Device Exemptions (IDEs) approved and actively enrolling patients (Coronary ISR,… more