Regulatory Affairs Director

Job purpose

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. 

Duties and responsibilities

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.