- 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
- Globus Medical, Inc. (Audubon, PA)
- …between sales and ERP Systems. **Cross-Functional Collaboration** + Collaborate with Finance, Regulatory Affairs , Supply Chain, and Marketing to align on demand ... critical role in driving the commercial success of our global medical device business. This individual will...has deep experience in sales operations within the medical device or healthcare technology industry, understands the regulatory… more
- BD (Becton, Dickinson and Company) (Salt Lake City, UT)
- …internal audits to evaluate effectiveness of GMPs and established Quality Systems + ** Regulatory Support:** Assist Regulatory Affairs by providing input for ... unit policies, while meeting all design control and other regulatory requirements. **Job Description** We are **the makers of...makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the… more
- Edwards Lifesciences (Phoenix, AZ)
- …Familiarity with FDA PMA applications. + Good knowledge of scientific research methodology, device development process, GCP, ICH guidelines and Global (US FDA, ... and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …Experience:** + Bachelor's degree. Typical degrees in Biological Sciences, Chemistry, and/or Regulatory Affairs . Other fields can be considered with the ... Description** We are **the makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the world of health (TM) is… more