Senior Director, Regulatory Affairs And Quality Assurance

This fast growth advanced medical device company has developed breakthrough imaging technology and is harnessing the power of artificial intelligence to enable quick, accurate, and non-invasive diagnoses for the precise treatment of cardiovascular disease.

The Senior Director of Regulatory Affairs and Quality Assurance is responsible for the end-to-end regulatory strategy of the company’s Software as a Medical Device (SaMD) products and Quality Assurance Systems. This is a key leadership position that will drive the regulatory strategy and build the QMS for products that will redefine healthcare for stroke and heart attacks.

Responsibilities include:

• Serve as Regulatory subject matter expert for the company, specific to Software as a Medical Device and Medical Device Imaging.
• Define, coordinate, and implement global device regulatory strategies for indication-specific development activities for key markets like the US, EU, UK, Japan, and China.
• Provide leadership and professional development to the RA/QS teams. Create a best-in-class RA/QS department and Quality Management System that can scale with the growth of the company. Manage outside regulatory consultants and writers.
• Guide global health agency interactions for the company with the FDA and discussions with international Health Authorities/Notified Bodies. Negotiate with regulatory authorities during the development process to ensure submission acceptance and approval.
• Drive global regulatory device strategies, registration, commercialization, and resolve software lifecycle challenges.
• Conduct training programs to educate employees on regulatory processes and requirements.
• Ensure compliance with product post-marketing approval requirements and submit reports as required.
• Review and approve advertising and promotional collateral to ensure regulatory compliance.

Required Educations and Skills:

• Advanced degree in Regulatory Affairs, Life Sciences, Engineering, or related.
• 10+ years of Regulatory Affairs experience in the medical device industry with proven success.
• 10+ years of Quality Management Systems experience in emerging medical technology development with a track record of successful inspections and certifications from regulatory agencies.
• Experience hiring and building high performing Regulatory and Quality teams.
• Specific regulatory submission expertise in 510(k), De Novo, technical documentation for EU MDR CE mark application, UKCA, PMDA, post-approval supplements and other relevant regulatory filings.
• Specific experience with FDA Class 2 SaMD products including CADt, CADe and CADx.
• Specific EU MDR experience in Class IIa/IIb Medical Device Software products.
• Knowledge of global device regulatory requirements (e.g., 21 CFR Part 820, EU MDR, ISO 13485, ISO 14971:2019, ISO 15223, IEC 62366, IEC 62304:2006, IEC 60601) is essential.
• Experience in Human Factors, Cybersecurity, Clinical Trials, Clinical Evidence Report generation and diagnostics.