- GE HealthCare (IL)
- …+ MD or equivalent medical degree required; + 10+ years in Pharmacovigilance, Medical Affairs and/or Regulatory Affairs in a Pharmaceutical company or CRO, ... of both marketed and investigational products. The ideal candidate will bring clinical expertise, regulatory awareness, and strategic insight to assess… more
- Cook Medical (Vandergrift, PA)
- Overview The Regulatory Affairs Specialist - Post Market Surveillance Specialist 2 will be involved in the development and generation of post market surveillance ... and Clinical Evaluation Reports (CERs) and responsibility for implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, MDR 2017/745, … more
- Edwards Lifesciences (Phoenix, AZ)
- …our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for ... Science/Medical Writing is responsible for supporting the development of regulatory and clinical documents for a dynamic...with 5 years of related experience working in medical affairs , clinical affairs and/or … more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Medical & Scientific Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs , Research & Development, Legal, and Health ... You will demonstrate the ability to apply your solid clinical experience, product expertise, and medical safety domain knowledge...+ Various standards (GCP, ISO 13485, ISO 14971) + Regulatory filings ( FDA IDE, 510K, EU-MDR CERs,… more
- Mallinckrodt Pharmaceuticals (St. Louis, MO)
- …of 15 years of pharmacuetical industry experience in a Quality Assurance and/or Regulatory Affairs function including experience in manufacturing and control of ... + Minimum 5 years managerial experience in a pharmaceutial quality/ regulatory affairs environment. Preferred Skills/Qualifications: + Previous experience… more
- J&J Family of Companies (Palm Beach Gardens, FL)
- …enabling the continuation of fast-growth in the Supply Chain platform. + Informing Regulatory Affairs as appropriate of substantial changes to Quality Systems. + ... than six million people moving each year while delivering clinical and economic value to surgeons and healthcare systems....retention to enhance the Quality talent pipeline. + Leads FDA /BSI and other foreign regulatory audits. +… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …and work closely with key members of internal departments including, Legal, Regulatory Affairs , Marketing, Global Health Economics, Value and Outcomes (Global ... HEVO), Clinical Research, Market Access / Managed Markets, Sales, and...This review is done in collaboration with Legal and Regulatory members (PARC, Promotional Advertising Review Committee) to ensure… more
- Terumo Medical Corporation (Somerset, NJ)
- …cross-functionally, will collaborate with internal stakeholders, to include Clinical Affairs , Professional & Clinical Education, Regulatory Affairs ... Marketing, Sales as well as external stakeholders, to include FDA , NB, PMDA, KOL, HCP, IRB and publishers. The...reports, documents and scientific presentations in cooperation with the Clinical , Medical, & Regulatory Affairs … more
- United Therapeutics (Research Triangle Park, NC)
- …across multiple functional groups (eg, Research and Development, Manufacturing, Validation, Regulatory Affairs , etc.). Negotiate and manage expectations across ... pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …areas. + Execute global internal audit activities for the Quality Assurance and Regulatory Affairs Function and tracks and coordinates audit corrective actions ... + Coordinates and leads audit activities with all global regulatory agencies (eg FDA , Notified Bodies, PMDA,...Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs … more