- Abbott (Plano, TX)
- … device regulations and guidelines, and product and therapeutic area knowledge to support Regulatory Affairs medical device submissions in the EU for ... in clinical research, clinical affairs , regulatory affairs , or quality systems, in the medical device or pharmaceuticals industry. + 3-5+ years of… more
- Astrix Technology (Fort Worth, TX)
- …EC Certificates (MDD /MDR) and associated documentation. **Key Requirements:** + 4+ years in medical device regulatory affairs + Experience with European ... ** Regulatory Affairs Specialist** Clinical Fort Worth,...Supporting EU MDR compliance and lifecycle change management for medical devices. + Works closely with site regulatory… more
- United Therapeutics (Austin, TX)
- …or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic ... ( **miroliver(R)** ), and a bioengineered external liver assist device for acute liver failure ( **miroliver** **_ELAP_** **(R)**...experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of… more
- Stryker (Flower Mound, TX)
- **Senior Project Manager, International Regulatory Affairs ** _San Jose, CA / Flower Mound, TX / Kalamazoo, MI_ Stryker is hiring a Senior Project Manager, ... International Regulatory Affairs , to expand global access to...+ 6+ years of experience in a regulated environment ( Medical Device , Pharmaceutical, Biomedical, or Automotive). +… more
- Fujifilm (Austin, TX)
- …**Job Description** **Responsibilities** + Manage and support the day-to-day legal affairs of assigned Medical Device businesses or ... Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with respect to healthcare… more
- Stryker (Flower Mound, TX)
- …May serve as Person Responsible for Regulatory Compliance (PRRC) under the EU Medical Device Regulation + May take responsibility for handling regulatory ... Provide a strategic direction and tactical focus to the Regulatory Affairs organization and influence the direction...ISO, FDA, and International requirements (ie, Medical Device Regulation) + Demonstrated expertise in regulatory … more
- Grifols Shared Services North America, Inc (Fort Worth, TX)
- …submissions. + May supervise staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of ... projects and issues affecting development of new products or medical devices or new indications for existing products +...years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the… more
- Cordis (Houston, TX)
- …key clinical and scientific insights to internal stakeholders-such as Clinical Development, Medical Affairs , and Commercial teams, helping shape strategy and ... and medical information between KOLs, other investigators and the company's Medical Affairs , Marketing and R&D groups. + Propose strategic solutions to… more
- Bausch + Lomb (Austin, TX)
- …Management, Clinical/ Medical Affairs , Biometrics, Regulatory Affairs , Quality Assurance, Pharmacovigilance/GPSS and Drug/ Device Safety, and Clinical ... in an accurate and timely manner. + Provide Clinical Operations support to the Regulatory Affairs department. Leadership: + Manage in-house team of CRAs, CTAs… more
- Edwards Lifesciences (Austin, TX)
- …pathology and physiology or Business Unit area of expertise + Moderate understanding of medical device regulatory requirements and documents, device ... + Knowledge of cardiovascular physiology and structural heart anatomy + Previous medical device Clinical Research experience in cardiology + Clinical research… more