The Regulatory Affairs Analyst – IVD Expert supports assigned regulatory tasks related to health authority notifications, submissions, and registrations regarding renewals and new products.

• Independently assemble and support maintenance of technical files and other regulatory documentation to ensure timely registrations and renewals.

• Maintain library/database of technical documentation.

• Monitor the status of standards and regulations. Know how on In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR; maintaining compliance with requirements of FDA 21 CFR 820, CMDR SOR 98-292, ISO 13485:2016, and other applicable International Medical Device Regulations is preferred.

• Act as liaison between site SME and internal country representatives.

• Maintain records of registration activities and license changes utilizing Good Documentation Practices.

Minimum Qualifications:

• Master’s degree in Pharmacy, Chemistry, Biology, Engineering, or other Life Science discipline

• 1-2 years of professional experience in Regulatory Affairs (IVD)

• Good knowledge of market, competitors, and authority landscape.

• Experience with Veeva Vault

• Experience with in-vitro diagnostics.

• Advanced written, oral, and interpersonal communication skills including proficient knowledge of medical terminology.

• Excellent organizational, prioritization, and problem-solving skills.

• Ability to work independently and effectively manage multiple tasks/projects with varying deadlines and requirements.

• Proficient in MS Office Software (Word, Excel, PowerPoint)

• Proficient in English and presentation skills.

• Excellent technical and report writing skills.

• Ability to effectively work both in a team situation and individually with minimal supervision.