Regulatory Affairs Specialist (Mammo)

The 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.

As the Regulatory Specialist, this position will:

• 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.

Please Note: This is not an exhaustive list of all duties, responsibilities and requirements of the position described above. Other functions may be assigned, and management retains the right to add or change duties at any time.

Qualifications include:

• 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.
• 2 - 4 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. 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 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

Working conditions

This position is based in the United States in a typical office setting.

This position will have the ability to work remotely.

Physical requirements

This position often requires sitting, standing, walking, bending, twisting, reaching with hands and arms, using hands and fingers, handling, or feeling, speaking, listening, and high-level cognitive thinking. Also, must be able to lift up to 10 pounds occasionally. The position requires the ability to travel (~10% of time), drive a vehicle, and utilize other forms of transportation.