Food And Drug Regulatory Director

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, enabling our customers to make the world healthier, cleaner and safer. With annual revenues of $10 billion, we have more than 30,000 employees and serve over 350,000 customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as environmental and industrial process control settings. Serving customers through two premier brands, Thermo Scientific and Fisher Scientific, we help solve analytical challenges from routine testing to complex research and discovery. Thermo Scientific offers customers a complete range of high-end analytical instruments as well as laboratory equipment, software, services, consumables and reagents to enable integrated laboratory workflow solutions. Fisher Scientific provides a complete portfolio of laboratory equipment, chemicals, supplies and services used in healthcare, scientific research, safety and education. Together, we offer the most convenient purchasing options to customers and continuously advance our technologies to accelerate the pace of scientific discovery, enhance value for customers and fuel growth for shareholders and employees alike. All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer. If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific. Thermo Fisher Scientific is an Equal Employment Opportunity and Affirmative Action employer. Job Description Food And Drug Regulatory Director Position Summary Advises businesses and other corporate staff on requirements of U.S. and foreign food and drug laws, with strong focus on medical devices.  Serves as subject matter expert (SME) and resource on related product laws and standards, both US and foreign.  Develops policies, provides training, audits, and provides other compliance assistance in these areas of responsibility.  Serves as senior specialist in these areas, mentoring and coordinating those specialists in these areas assigned to affected businesses, to include leading company FDA network among those businesses. Serves as Official Correspondent for Thermo Fisher with US FDA.  Comments on and influences regulatory developments in these area.Minimum Requirements/Qualifications: Undergraduate degree in technical specialty (e.g. engineering, chemistry, or biology) required. Graduate education in similar field or law desired. Minimum ten years U.S. industrial or government experience with food and drug laws particularly those relating to medical devices/biotechnology including in vitro diagnostic devices required.  Hands-on experience with classification of devices: listing, registration, and approval of devices; adverse event reporting, corrective and remedial actions and recalls required. Knowledge of the requirements of current Good Manufacturing Practice ("GMP"), FDA Quality Systems Regulation and ISO quality assurance  required. Experience with similar ex US (e.g. Canada, China, EU, Japan) food and drug laws strongly desired. Experience with EU IVD, Food Chemical Codex, US Pharmacopoeia, Canadian Standards, and CE marking strongly desired. Experience with medical device and/or drug approvals and follow-up and direct and indirect food additives desired. Experience working in a matrix environment.  Familiarity with Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA") and Toxic Substances Control Act ("TSCA"), and EU REACh, RoHS, and WEEE desired. Experience building efficiencies at multiple sites with multiple products highly desirable. Ability to travel (approximately 25-35 percent) required. Excellent communication and organization skills required. Proven leadership skills, strong presence and the ability to influence others in a matrix environment required. Self-motivated with high integrity and energy.Non-Negotiable Hiring Criteria:  Bachelor’s degree required in technical specialty  10 years of experience with progressive experience similar roles required  3 years of experience with Good Manufacturing Practice “GMP” required  2 years of global experience required  Ability to travel 25-35 percent required  Strong working knowledge of FDA and pertinent rules and regulations requiredEducation: BachelorsJob Level: Director