- 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
- Bio-Techne (Austin, TX)
- …global regulatory strategies, ensuring compliance with FDA and international medical device regulations. Monitor industry trends, analyze regulatory ... ability to manage workload independently. + Applied knowledge of FDA and international medical device regulations, global regulatory strategy, and submission… 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
- 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
- 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
- Abbott (Plano, TX)
- …of product complaints; Be able to make sound decisions regarding medical device reporting to various global regulatory agencies, minimizing the need for ... extracted from the complaint database to various teams (eg Regulatory , Quality Engineering). Another role of the...database. Independently assesses the complaint to determine if a medical device report needs to be filed… more
- Danaher Corporation (Austin, TX)
- …of the job include: + Bachelor's degree in science with 14+ years of clinical quality /GCP experience within the device industry OR + Master's degree in science ... Clinical Affairs department, in addition to responses to global regulatory submissions following US and CE IVD approvals. +...with 12+ years of clinical quality /GCP experience within the device industry +… more
- Abbott (Irving, TX)
- …business competencies that drive results and continuous improvement. + Knowledgeable of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more