Regulatory Affairs Specialist

A recognized global leader in Assisted Reproductive Technology (ART) is seeking an experienced Regulatory Affairs Specialist for a 6-month+ contract assignment. The ideal candidate will have direct experience with international regulatory standards governing medical devices and in vitro diagnostics (IVDs), including GMP, ISO 13485, MDR 2017/745, MDD, IVDD, ISO 14971, and CMDR. Key Responsibilities: Manage and maintain international product registrations (EU, China, ROW). Support preparation and submission of US FDA 510(k)s, EU Technical Files, and other global filings. Update Technical Files and RA/CA SOPs to reflect regulatory and organizational changes. Monitor compliance with country-specific registration and distribution regulations.

Review and interpret relevant standards, guidance documents, and regulations. Support internal/external audits, design changes, and field actions e. g. , recalls, adverse event reporting, etc. Collaborate cross-functionally to ensure global regulatory compliance. Prepare regular reports on registration status and regulatory activity. Qualifications: 3–5 years of Regulatory Affairs and/or Quality Assurance experience in medical device or pharmaceutical industries. In-depth knowledge of global regulatory requirements e. g. , GMP, ISO 13485, CFRs, etc. Direct experience with risk management (FMEA), process validation, and QA practices. Familiarity with cell and tissue culture or embryology is preferred (industry or academic).

Proficiency in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.