A medical device company is looking for Head of Regulatory Affairs Quality Assurance.
Responsible for leading all Regulatory Affairs and Quality Assurance activities across the product lifecycle. This role drives global regulatory strategy (FDA, CE, and international markets) and builds scalable QMS infrastructure in a fast-paced startup environment.
Key Responsibilities
Lead global regulatory strategy and submissions (IDE, 510(k), De Novo, PMA).
Develop and maintain QMS; ensure compliance with ISO 13485, FDA QSR, and EU MDR.
Lead audits, inspections, and certification processes.
Oversee Technical Files, DHFs, and risk management documentation.
Partner with R D, Engineering, and Clinical teams to support compliant product development and foster a strong quality culture.
Requirements: B.Sc. - Mandatory
M.Sc. -an advantage
7+ years of experience in RA/ QA within the medical device industry
Proven leadership experience in multidisciplinary environments (e.g., electronics, algorithms, software, mechanics, physics, materials)
Strong expertise in EU MDR, FDA 21 CFR Part 820, ISO 13485, and global regulatory frameworks
Demonstrated experience managing regulatory submissions and audits
Excellent communication skills and ability to work effectively across teams
High proficiency in English (written and spoken)
This position is open to all candidates.