The Regulatory Affairs Analyst is responsible for maintaining regulatory compliance to all applicable regulatory requirements.
The Regulatory Affairs Specialist will ensure regulatory compliance by completing thorough assessments and the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies.
Requirements: Knowledge, Skills and Experience Prepare complex submissions to gain global approvals for clinical research, export, and commercial distribution, such as: IDE, 510(k), PMA, Shonin, Design Dossier and Technical File. Apply regulatory standards, guidance documents, and industry expectations to product strategies and submissions. Guides others in the organization who are working on similar products. Identify requirements and potential obstacles for new product development teams. Demonstrate knowledge and skills in areas of regulatory pathways, risk-benefit analysis, communication and collaboration internally and external, submission, registration, obtaining approval/clearance, documentation, post marketing compliance. Demonstrate strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities. Possess and apply a broad and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures. Author and update SOPs, recommend timely changes to ensure regulatory compliance, and lead process improvements to maximize efficiencies Develop and maintain positive relationships with regulatory agencies through oral and written communications regarding pre-submissions strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review. Lead negotiations and interactions with regulatory authorities during the development and review process to ensure submission approval/clearance. Advise personnel on regulatory requirements for quality, preclinical and clinical data requirements for clinical study applications or marketing applications. Provide regulatory input to product lifecycle planning. Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions. Review of advertising and promotional items. Assist in SOP development and review. Education, Certification, Licensure, and/or Experience A Bachelors Degree (B.S or B.A) in Engineering, Science or equivalent focus is required. A minimum of 5 years of experience in an FDA regulated industry. A minimum of 3 years of Regulatory Affairs experience. Regulatory Experience required (e.g., 21 CFR Part 820, ISO 13485, MDSAP). RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.