- Actalent (Fort Worth, TX)
- …ensure consistent implementation of quality systems. Essential Skills + Medical device quality assurance + FDA regulatory affairs + Process and ... preferred + Minimum of 8 years in quality and regulatory leadership roles within the medical device industry + Proficiency in additional languages is a… more
- Chemours (Austin, TX)
- …Engineering, Biological Science, Toxicology or comparable technical field + 5+ years of medical device regulatory compliance experience with respect to raw ... outside lawyers, consultants, industry associations, and local agencies on specific medical regulatory topics. + Coordinate and review customer… 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 MDR ... and project timelines. + Collaborates cross-functionally to ensure timely, high- quality regulatory submissions and supports continuous improvement initiatives.… more
- United Therapeutics (Austin, TX)
- …of biologic 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 ... ( **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… 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 ... more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has… more
- Stryker (Flower Mound, TX)
- …a related field + 10+ years of experience in a regulated environment ( Medical Device , Pharmaceutical, Biomedical, or Automotive). + Experience leading and ... access strategies, leveraging advanced project management practices in areas such as regulatory , quality , risk, procurement, and stakeholder engagement. You will… more
- Abbott (Plano, TX)
- …years of experience in clinical research, clinical affairs, regulatory affairs, or quality systems, in the medical device or pharmaceuticals industry. + ... guidelines, and product and therapeutic area knowledge to support Regulatory Affairs medical device submissions...Bachelor's Degree + Minimum 2 years of experience in regulatory preferred but may consider quality assurance,… more
- Abbott (Austin, TX)
- …Monitoring Systems (strips, meters & accessories), FreeStyle Libre portfolio of products, medical device combination products, new medical sensors, Lingo ... + Bachelors Degree with a minimum 5+ years of progressive work experience in medical device . + Proven ability to manage and coordinate multiple concurrent… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment + Strong knowledge of current global Good ... an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will...Previous experience of working in the global pharmaceutical and medical device industry. + Experience working with… more
- Edwards Lifesciences (Dallas, TX)
- …pathology and physiology or Business Unit area of expertise + Moderate understanding of medical device regulatory requirements and documents, device ... in clinical research monitoring, with a strong focus on quality assurance, quality control, and regulatory...of cardiovascular physiology and structural heart anatomy + Previous medical device Clinical Research experience in cardiology… more