Regulatory Affairs Specialist

Role: Regulatory Affairs specialist supporting global compliance for IVD products across markets including US, EU, Canada, LATAM, Asia-Pacific, and Middle East. Objectives: ensure timely regulatory submissions, maintain compliance, and facilitate market access throughout product lifecycle. Responsibilities: prepare and submit documentation for product registration, monitor evolving regulations, update compliance processes, support post-market activities like vigilance and recalls, and collaborate with R&D, Quality, and Commercial teams on regulatory integration. Qualifications: Bachelor's degree, minimum 3 years in regulated medical devices or IVD, strong knowledge of international regulatory standards (e.g., IVDR, ISO 13485, MDSAP), and experience with electronic QMS platforms such as MasterControl or Veeva Vault. Preferred: experience with antibody-based diagnostics and familiarity with global markets, including LATAM, EU, and MDSAP countries. HighValue: IVD regulatory compliance, global submissions, IVDR, ISO standards, post-market surveillance, and cross-functional collaboration. WorkSetup: full-time remote, with occasional local travel less than 20%.