Director of Regulatory Affairs and Quality Assurance

Job Description

Responsible for design and implementation of policies and procedures related to medical devices (no pharma) to insure quality and regulatory standards are met; that company products meet defined and documented specifications; and that they comply with applicable Federal, State and International regulations and standards governing the medical device industry, including but not limited to Federal Food and Drug Administration (FDA), European Medical Device Regulation (MDR), Canadian Medical Device Regulations, International Organization for Standardization (ISO), Underwriters Laboratories (UL), U.S. Occupational Safety and Health Administration (OSHA), U.S. Environmental Protection Agency (EPA), American Society of Testing and Materials (ASTM), American National Standards Institute (ANSI). Leads and directs the works of others.Bachelor's degree from accredited college or university; with 10 years related medical device experience; or equivalent combination of education and experience is required. Advanced degree a plus.Experience in regulatory submissions (510ks) and tech files a plus.ASQC CQM a plus.Thorough understanding of FDA QSR (21 CFR 800-860), EU MDR, MDSAP, ISO, as applicable to company business; knowledge of ASTM, UL, CSA, ANSI, EPA, and U.S. Customs Regulations as applicable to company business.Must be able to prioritize, organize, and delegate assignments and handle multiple tasks / projects simultaneously.Benefits : 401(k) plus matchingHealth insuranceDental insuranceVision insuranceEmployee assistance programFlexible spending accountHealth savings accountLife insurancePaid time off - 40 hours after 90 days, and 40 hours after six months on year 1.Schedule : (on-site)8 hour shifts - Monday to FridayExperience : FDA regulations : 5 years (Required)Sr Level Quality Assurance and Regulatory : 5 years (Required)MDR / MDSAPAbility to Commute : Clearwater, FL 33762 (Required)Able to travel to conduct supplier audits

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