Regulatory Affairs Director

RadNet•Somerville, MA

10d•Remote

About The Position

Reporting to the Head of Quality, Regulatory, and Compliance, the Director of Regulatory Affairs is responsible for executing regulatory strategies, ensuring compliance with global regulations and leading the process to obtain and maintain market approval for DeepHealth's product and product development and regulatory activities to commercialize new digital products, including AI technologies. This position will provide regulatory input on design and development activities to cross-functional teams, to ensure compliance with the relevant regulatory requirements and interactions with regulatory authorities. As the Regulatory Affairs Director, this position will: Help to develop and implement the global regulatory strategies, such that they align with business objectives. Manage and develop a team of global regulatory professionals, providing performance managements, and ensure staff are appropriately trained. Ensure the organization's products and operations comply with local, national, and internation regulations. Contribute to and execute the regulatory strategies for existing, new and modified medical and non-medical devices. 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 device. Serve as a contact point with regulatory submission, managing communications and submissions. Lead and manage regulatory submissions, including US 510(k)s submissions, and technical files for CE marking, including Regulatory Body interactions. Mentor and provide guidance to their direct reports and cross-functional product development teams on regulatory requirements, specifically for the US, UK, and EU markets. Work closely with business partners and regulatory team members to ensure compliance for and support of OUS regulatory submissions and filings. Monitor and interpret evolving global regulations, standards, and guidance documents to ensure the company's regulatory compliance, translating them into action steps for the organization. Manage SOP development and review in support of "next-gen" product offerings. 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 Evaluate proposed design, labeling, and distribution changes for regulatory impact and implement any required regulatory action. Ensure compliance with product post marketing requirements. 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.

Requirements

Bachelor's degree in relevant field (or equivalent experience)
15+ 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 for Software as Medical Device.
Experience with US FDA Class I and II medical devices.
Experience interacting with US and OUS 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

Nice To Haves

Additional experience with FDA Class III devices and OUS device classification a plus.

Responsibilities

Help to develop and implement the global regulatory strategies, such that they align with business objectives.
Manage and develop a team of global regulatory professionals, providing performance managements, and ensure staff are appropriately trained.
Ensure the organization's products and operations comply with local, national, and internation regulations.
Contribute to and execute the regulatory strategies for existing, new and modified medical and non-medical devices.
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 device.
Serve as a contact point with regulatory submission, managing communications and submissions.
Lead and manage regulatory submissions, including US 510(k)s submissions, and technical files for CE marking, including Regulatory Body interactions.
Mentor and provide guidance to their direct reports and cross-functional product development teams on regulatory requirements, specifically for the US, UK, and EU markets.
Work closely with business partners and regulatory team members to ensure compliance for and support of OUS regulatory submissions and filings.
Monitor and interpret evolving global regulations, standards, and guidance documents to ensure the company's regulatory compliance, translating them into action steps for the organization.
Manage SOP development and review in support of "next-gen" product offerings.
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
Evaluate proposed design, labeling, and distribution changes for regulatory impact and implement any required regulatory action.
Ensure compliance with product post marketing requirements.