Sr. Regulatory Affairs Specialist

Regulatory Affairs Representative

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.

Assist 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.

Assist 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.

Individuals may 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.

Ensuring 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