Regulatory Affairs Manager – Medical Device Company – NEW ROLE!
Position Summary/ Objectives: The Manager of Regulatory Affairs will provide leadership to the Regulatory Affairs department, including the participation in allocation and management of department resources, to accomplish corporate objectives. This position ensures that the solid execution of company programs remain consistent with the overall company values. The successful candidate will possess a high degree of professionalism, maturity and confidentiality. Essential Job Functions: Possess current knowledge of existing and emerging Medical Device regulations, directives, standards, and guidance documents (i.e. FDA, ISO, EN, MDR, MDD, etc.). Communicate regulatory rules or rule changes and ensures that they are effectively implemented through corporate policies and procedures. Develop regulatory strategies to support device designs from inception through post-approval on a global basis. Guide project teams effectively. Collaborates effectively with management, Subject Matter Experts (SMEs), and peers to design cross-functional solutions with regards to regulatory strategies. Collaborate with project teams and provides advice on subjects such as premarket regulatory requirements, labeling requirements, and post-market surveillance requirements. Coordinate, support, and author clear and concise regulatory filings for both domestic and international product registrations. Coordinate, support, and author clear and concise regulatory responses to requests for additional information by regulatory agencies. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance requirements, or clarification and follow-up of submissions under review. Guide, review, and identify requirements for risk management of animal tissue related risks. Review Engineering Change Orders for the regulatory function and determines regulatory status/filing requirements. Review product labeling, including internal and external promotional material and marketing literature, for compliance with applicable regulations and policies. Review clinical protocols to ensure collection of data needed for regulatory submissions. Evaluate post market surveillance data. Develop and conducts employee training. Coordinate Corrective/Preventive Action Requests as related to the regulatory department. Analyze product complaints and make recommendations regarding their report-ability. File Medical Device Reports and Vigilance Reports. Coordinates recall or market withdrawal activities as necessary. Assist in establishing regulatory budget. Assist in conducting performance reviews, where applicable. Position Authorities Initiate, recommend, or provide solutions through designated channels. Initiate action to correct or prevent the occurrence of any nonconformities relating to product, process and quality system. Regulatory approval of labeling. Regulatory approval of Engineering Change Orders Signs Purchase Orders related to Regulatory Education, Experience and Certification: Ability to follow written and oral instructions with minimum supervision. Good communication skills, both verbal and written reports. A strong understanding of global regulatory requirements for medical devices, including FDA cGMP/QSR, ISO13485, Canadian MDR, and the MDD/EU MDR. Bachelor’s Degree or equivalent in biological sciences or engineering with a minimum of 6-years’ experience in medical devices or similar industry; knowledge of animal tissue standards preferred. Possess a working knowledge of State and Federal Employment Law Excellent written and verbal communication skills Years Experience: 5 – 10 years Bonus/Commission: Yes
Qualified candidates are invited to send resumes to email@example.com.
Job posted: 2020-11-18