- Chemours (Austin, TX)
- …Engineering, Biological Science, Toxicology or comparable technical field + 5+ years of medical device regulatory compliance experience with respect ... outside lawyers, consultants, industry associations, and local agencies on specific medical regulatory topics. + Coordinate and review customer… more
- Fujifilm (Austin, TX)
- …to Division General Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with ... part of the legal team providing support to the Medical Device businesses of FUJIFILM Healthcare Americas...respect to healthcare regulatory compliance , anti-kickback statutes, the False Claims Act, US government… more
- Bio-Techne (Austin, TX)
- …strategies, ensuring compliance with FDA and international medical device regulations. Monitor industry trends, analyze regulatory changes, and provide ... ability to manage workload independently. + Applied knowledge of FDA and international medical device regulations, global regulatory strategy, and submission… more
- Cardinal Health (Austin, TX)
- …functions and teams and delegate and direct non-legal tasks to support regulatory compliance implementation. **_Qualifications_** * Bachelor and JD degrees ... regulation) preferred * Experience in private practice strongly preferred * Familiarly with medical device and pharmaceutical regulation * Active license in good… 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 ... more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has… more
- Fotona (Irving, TX)
- … regulatory affairs, legal compliance , or risk management, ideally within the medical device , life sciences, or healthcare sector. + Deep expertise in FDA ... ease of use, and durability. Fotona is currently seeking a seasoned Director of Compliance to lead regulatory and corporate compliance efforts, with a… more
- Abbott (Plano, TX)
- … device regulations and guidelines, and product and therapeutic area knowledge to support Regulatory Affairs medical device submissions in the EU for CE ... to new product development teams and sustaining teams. + Compliance with applicable corporate and divisional policies and procedures.... regulatory affairs, or quality systems, in the medical device or pharmaceuticals industry. + 3-5+… more
- Danaher Corporation (Austin, TX)
- …which makes everything possible. The Senior Manager, Clinical Quality and Compliance reporting to the Senior Director of Clinical Compliance ... limited to the United States and Europe. This role also provides clinical compliance support for pre-market clinical studies. This position is part of the Clinical… more
- Danaher Corporation (Austin, TX)
- … programs and teams in metric/KPI-driven global manufacturing organizations in medical device manufacturing or other highly-regulated sectors. + Deep ... and identify process improvement opportunities. + Develop and implement comprehensive compliance training programs that ensure regulatory awareness and expertise… more
- Edwards Lifesciences (Dallas, TX)
- …pathology and physiology or Business Unit area of expertise + Moderate understanding of medical device regulatory requirements and documents, device ... trial patients' safety by assuring trials are conducted ethically and within regulatory compliance , data accuracy, and protocol adherence. The ideal candidate… more