Senior Regulatory Specialist
November 21
Description
• The Senior Regulatory Specialist (US) is responsible for supporting DeepHealth’s product and product development, ensuring compliance with the relevant regulatory requirements and interactions with regulatory authorities. • Plan, define and coordinate relevant process related to product Regulatory approval, including but not limited to, FDA clearance, and/or CE Marking. • Actively liaise and closely collaborate with engineering and product teams to ensure regulatory compliance for product markets. • Provide regulatory guidance to the development teams for registration of products. • 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 DeepHealth products. • Plan, execute and document (clinical) risk assessment sessions with relevant internal and external experts. • Work with the clinical teams to ensure compliance for pre- and post-market clinical studies in support of DeepHealth products and product changes. • Enforce compliance to applicable standards and escalate to appropriate authorities if needed. • Ensuring timely submission of adverse events to the appropriate regulatory bodies.
Requirements
• Bachelor’s degree in relevant field (or equivalent experience) • Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820 • 6-8 years working in a regulated industry (FDA and Software as a Medical Device preferred) • Knowledge and experience drafting and submitting regulatory filings, including but not limited to, Q-Submission requests, and Traditional and Special 510(k) filings • 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 Regulatory Authorities, including Q-Submission meetings, and product Deficiency Response meetings, and regulatory inspections • 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
Benefits
• Join a dynamic team with expertise in various fields. • Collaborative and agile work environment. • Continuous learning opportunities to enhance your professional skills. • Fully remote working environment with Flexibility in work hours. • A salary in line with job level and experience.
Apply NowSimilar Jobs
November 21
Collaborate with regulatory teams to lead labeling strategies at BridgeBio. Ensure effective regulatory compliance for global labeling activities.
November 21
As a Senior Regulatory Associate, ensure compliance and drive strategy in Home & Personal Care at Arxada.
November 21
Lead U.S. regulatory strategy within Sumitomo Pharma's Global Regulatory Affairs team, overseeing regional regulatory plans and submissions. Collaborate on FDA regulations for product promotion and advertising.
November 17
Senior Director for Commercial Regulatory Affairs at a biopharmaceutical company addressing rare diseases, overseeing promotional materials and compliance.
November 16
Lead the maturing of the Enterprise Risk and Compliance program at Toast. Drive risk management processes for the restaurant platform.