What are the responsibilities and job description for the Sr. Regulatory Affairs Specialist position at Katalyst CRO?
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.
- 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