Sr. Regulatory Affairs Specialist

Responsibilities

• Represent Regulatory Affairs on cross-functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for non-medical devices, and medical devices.
• Assess the acceptability of documentation for medical device submissions and effectively communicate regulatory guidance.
• Aid in SOP development and review in support of "next-gen" product offerings.
• Revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.
• Understand and investigate regulatory history/background of class, disease/therapeutic context in order to assess regulatory implications for approval.
• Create and ensure maintenance of technical documentation (such as clinical evaluation reports, risk management reports, 510(k) notification) as required for obtaining and/or maintaining regulatory approval/clearance for Client products.
• Aid in preparation and review of regulatory submission to authorities.
• Evaluate proposed design, labeling, and distribution changes for regulatory impact and implement any required regulatory action.
• Utilize technical regulatory skills to propose strategies on complex issues.
• Ensure compliance with product post marketing requirements.
• Review product labeling to ensure compliance with relevant regulatory requirements.
• Provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees.
• Participate in the development of less experienced staff by setting an example, providing guidance, and offering counsel.
• Work with the clinical teams to ensure compliance for pre- and post-market clinical studies in support of client products and product changes.
• Ensure timely submission of adverse events to the appropriate regulatory bodies.

Requirements

• Bachelor's degree in relevant field (or equivalent experience)
• 6 - 8 years working in a regulated industry (FDA and Software as a Medical Device preferred)
• Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820
• Knowledge and experience drafting and submitting regulatory filings, including but not limited to, Q-Submission requests, and Traditional and Special 510(k) filings. Filings for Software as Medical Device preferred
• Experience with US FDA Class I and II medical devices
• Additional experience with FDA Class III devices and OUS device classification a plus
• Experience interacting with OUS Regulatory Authorities, including Q-Submission meetings, and product Deficiency Response meetings, and regulatory inspections and US
• Knowledge and understanding of pre- and post- market clinical studies, including but not limited to, 21 CFR 812, 21 CFR 50, and 21 CFR 56
• Knowledge and understanding of Medical Devices Regulations (MDR 2017/745. MDCG 2019-11, MDCG 2020-1), ISO 13485, and MDSAP, ISO 14971, ISO 62366, IEC 82304-1, IEC 62304, preferred
• Excellent written and oral communication skills