Lead Regulatory Affairs Strategy for Advanced Medical Technologies
This role directs regulatory planning and execution for novel medical devices, including wearable systems and artificial intelligence-driven Software as a Medical Device (SaMD). You will develop and implement global regulatory pathways aligned with business goals, ensuring adherence to U.S. FDA, EU MDR, and international standards.
Key Responsibilities
- Design and manage regulatory strategies for new and modified devices, from concept through post-market phases
- Lead preparation and submission of FDA filings, including 510(k) and pre-submission packages, for SaMD and wearable technologies
- Oversee team performance, including work planning, mentorship, and professional development of regulatory associates
- Serve as primary regulatory expert on AI, cybersecurity, and SaMD, advising cross-functional teams on compliance requirements
- Prepare and submit technical documentation for EU MDR and other international markets
- Review and approve promotional materials, design changes, and labeling to ensure regulatory alignment
- Develop and maintain regulatory tools, matrices, and SOPs to strengthen team capability and quality systems
- Monitor evolving global regulations and assess impact on product strategies and registration timelines
- Interface with regulatory agencies during review cycles to support timely clearance
- Support internal and external audits, ensuring regulatory readiness across product lines
Qualifications
A Bachelor’s or Master’s degree in engineering, life sciences, or a related discipline is required. Candidates must have 6–10 years of regulatory experience in the medical device industry, with direct involvement in FDA submissions, SaMD development, and compliance with 21 CFR 820, EU MDR, ISO 13485, IEC 62304, ISO 14971, and HIPAA. Proven experience in crafting risk-based regulatory strategies and managing product lifecycle changes is essential. Experience with wearable devices and global regulations is advantageous. Strong project management, communication, and problem-solving abilities are expected. Occasional travel (5–10%) may be required.
Work Environment
This position supports remote work within the United States and offers flexibility without compromising collaboration. The role operates in a fast-paced, innovation-driven environment focused on advancing cardiac care through technology.
Compensation & Benefits
The salary range for this position is $127,000 to $165,000 annually, with eligibility for a 401(k) plan featuring company matching and an Employee Stock Purchase Plan. Comprehensive benefits include medical, dental, and vision coverage, paid time off, and company-sponsored events. The organization is committed to fostering an inclusive, purpose-driven culture that supports growth, innovation, and career advancement.
