VP, Regulated Device Engineering
About The Position
The VP, Regulated Device Engineering is responsible for the overall leadership, strategy, and execution of the company’s regulated medical device business organization. This role owns end-to-end product development, from concept through commercialization, ensuring compliance with all FDA and global regulatory requirements while driving innovation, quality, and operational excellence. This leader will directly oversee Research & Development and have cross-functional influence with Quality, Regulatory Affairs, Clinical, and Manufacturing to ensure successful product development, approval, and market adoption.
Requirements
- Bachelor’s degree in Mechanical Engineering
- 15+ years of experience in the medical device industry, with significant experience in Class II devices
- Proven leadership experience overseeing R&D teams and product development pipelines
- Deep knowledge of FDA regulations, including 21 CFR Part 820, and international standards such as ISO 13485 and ISO 14971
- Demonstrated success leading products through regulatory clearance (e.g., 510(k)) and commercialization
- Experience working closely with Quality and Regulatory functions in a design controlled environment
Responsibilities
- Define and execute the strategic roadmap for the regulated devices portfolio, aligned with company growth objectives
- Own budgeting, and resource allocation for the regulated devices business unit
- Partner with executive leadership to identify new product opportunities
- Build and scale a high-performing, cross-functional organization
- Directly lead R&D developing regulated medical devices from concept through design transfer and commercialization
- Ensure design control processes are robust, compliant, and efficiently executed (21 CFR Part 820, ISO 13485)
- Drive innovation while maintaining disciplined product development processes, including risk management (ISO 14971) and usability engineering
- Ensure all products meet FDA, international regulatory, and quality system requirements
- Partner closely with Quality and Regulatory leaders to support successful submissions (e.g., 510(k), De Novo as applicable)
- Champion a culture of quality and compliance across the organization
- Ensure inspection readiness and successful audits (FDA, notified bodies, etc.)
- Provide indirect leadership and alignment across Clinical, Manufacturing, and Supply Chain
- Ensure clinical strategies support regulatory and commercial objectives
- Collaborate with Manufacturing/Operations to ensure scalable, cost-effective, and compliant production processes
- Establish and monitor KPIs across development, quality, regulatory, and manufacturing readiness
- Drive continuous improvement in product development lifecycle, time-to-market, and cost efficiency
- Identify and mitigate technical, regulatory, and operational risks
Benefits
- Competitive salary & equity compensation for full-time roles
- Unlimited PTO, company holidays, and quarterly mental health days
- Comprehensive health benefits including medical, dental & vision, and parental leave
- Employee Stock Purchase Program (ESPP)
- 401k benefits with employer matching contribution
- Offsite team retreats
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Executive
