Principle Regulatory Affairs Specialist
COLLINS MCNICHOLAS RECRUITMENT
Principal Regulatory Affairs Specialist. Responsible for managing all facets of regulatory support products. This includes developing regulatory submissions, managing departmental projects, requesting and reviewing site specific labeling, and providing guidance and consultation for domestic and international regulations, interacting with governmental agencies. Principal Duties and Responsibilities. Management of the RA function for all manufacturing transfers, manufacturing process changes, introduction of new critical vendors and new product introductions. This includes creating regulatory strategies and managing the execution of these to ensure minimal interruption in commercialization. Management of the submission of registration documentation to relevant regulatory agency or local representative: Prepares/Reviews Change Notifications to the EU design dossier for EU Class III products. This includes hosting on-site reviews by the Notified Bodies and being the main contact for reviews. Prepares/Reviews PMA supplements to FDA (Real Time Requests, 30 Day Notices, and Manufacturing Site Change Supplements) for changes to US Class III products/process. Preparation of the site portion of the Annual Report for US Class III products to FDA. Regulatory approval of labelling for product transfers or new product introduction in accordance with relevant labelling requirement. Management of the renewal of licenses for currently marketed medical devices. Management of all Regulatory assessments including managing field notifications in relation to the modification to existing products and introduction of new products using relevant guidance documents. Responds to requests from relevant regulatory agency or local representative relating to previously submitted documentation for marketing approval. Keeps all areas of informed of regulatory requirements and emerging issues which may affect the registration approval of products. Interprets and applies FDA regulations to business practices and provides regulatory input, advise, and guidance to the organization. Establishes RA policies and procedures and ensures compliance with them. Communicates with Regulatory/Governmental agencies. Responsibility for oversight and prioritization of departmental tasks and projects. Miscellaneous responsibilities as assigned. Expected Areas of Competence (i.e. KSAs. Demonstrated strong writing and communication skills; ability to communicate effectively at multiple levels, including with regulatory agencies, superiors, peers, Strong interpersonal, organizational, problem-solving and analytical skills; strong attention to detail. Ability to manage competing priorities; ability to manage projects of various sizes, constitutions, and management of personnel; versatility, flexibility, and willingness to work with changing priorities. Demonstrated strong knowledge of relevant regulations, and ability to stay abreast of regulations. Ability to function well as a member of the team and team leader, as well as build relationships between RA and other areas of the organization. Ability to identify and assess business risks to develop Regulatory strategy. Ability to handle increasing levels of responsibility. Ability to build and lead a strong RA team; ability to lead and influence others. Strong computer skills. Ability to negotiate with regulatory agencies, management, and other groups as necessary. Advanced knowledge of FDA and EU regulations (including labeling regulations) and regulations outside of the US/EU as applicable. Education/ Experience Requirements. Bachelor’s degree required; concentration in life sciences, technical/engineering or related field, preferred. 6-8 years of experience in Regulatory Affairs, including preparation of submissions to the FDA/EU. A minimum of 3 years of experience in medical device, drugs, biologics, and/or combination products, preferred. Regulatory Affairs Certification (US or EU) preferred. A combination of education, experience, leadership, strategy and RA influence may be considered. For more information on our Recruitment and HR Services, and to see a full list of our available jobs across Ireland, please visit our website at www.collinsmcnicholas.ie. Follow us on LinkedIn and connect with our consultants to discuss all the latest jobs!.
10 days ago