Sr. Regulatory Affairs Specialist

The Sr. Regulatory Affairs Specialist is responsible for supporting DeepHealth’s product and product development and regulatory activities to commercialize new digital products, including AI technologies.  In this role, the Sr. Regulatory Specialist 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 Sr. Regulatory Affairs Specialist, this position will: 

• 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 DeepHealth 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. 

• Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees. Participates 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 DeepHealth products and product changes. 

• 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 

Qualifications include: 

• Bachelor’s degree in relevant field (or equivalent experience) 

• 8 - 12 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.  Additional experience with FDA Class III devices and OUS device classification a plus.  

• 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 

  Working conditions 

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.