Vice President Regulatory Affairs

VP of Regulatory Affairs & Quality AssuranceI’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 ResponsibilitiesLead global regulatory strategy and submissions across multiple programs and geographiesOversee and continuously enhance the Quality Management System (QMS) to support a multi-product, multi-market environmentPartner cross-functionally with R&D, Clinical, and Manufacturing to support product development, scale-up, and lifecycle managementDrive design controls, risk management, and post-market surveillance activities across a range of technologiesInterface with regulatory authorities, notified bodies, and external partners on a global scaleQualifications10–15+ years of experience in Regulatory Affairs and/or Quality within medical devices or combination productsExperience across Class II and/or Class III products, including hardware and/or software-driven technologiesBackground 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 frameworksExperience operating within complex, multi-program environmentsAbility to lead strategically while remaining close to executionCompensation: $200,000 - $225,000 base + bonus + equityTo 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.