VP of Regulatory Affairs & Quality Assurance
I’m partnering with an innovative medical device organization seeking a senior leader to oversee Regulatory Affairs and Quality across a broad portfolio of medical technologies spanning multiple programs, indications, and product types. This individual will play a key role in shaping global regulatory strategy, supporting clinical and product development activities, and ensuring compliance across complex and evolving markets.
Key Responsibilities
- Lead global regulatory strategy and submissions across multiple programs and geographies
- Oversee and continuously enhance the Quality Management System (QMS) to support a multi-product, multi-market environment
- Partner cross-functionally with R&D, Clinical, and Manufacturing to support product development, scale-up, and lifecycle management
- Drive design controls, risk management, and post-market surveillance activities across a range of technologies
- Interface with regulatory authorities, notified bodies, and external partners on a global scale
Qualifications
- 10–15+ years of experience in Regulatory Affairs and/or Quality within medical devices or combination products
- Experience across Class II and/or Class III products, including hardware and/or software-driven technologies
- Background supporting multiple regulatory pathways (e.g., 510(k), PMA, De Novo, and international submissions)
- Strong knowledge of ISO 13485, 21 CFR Part 820, and global regulatory frameworks
- Experience operating within complex, multi-program environments
- Ability to lead strategically while remaining close to execution
Compensation: $200,000 - $225,000 base + bonus + equity
To be considered, please apply with your resume or email scot.widjaja@lumicity.io for further consideration. If this sounds like something right up your ally, I certainly would love to connect.
