Regulatory Affairs Analyst

We are hiring for Regulatory Affairs Analyst IVD Expert

Your Role:

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.

Who you are:

Minimum Qualifications:

Masters degree in Pharmacy, Chemistry, Biology, Engineering, or other Life Science discipline

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

Preferred Qualifications:

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.

Please use the below link for job application and quicker response.

https://lifelancer.com/jobs/view/bb2f766e763f67498c045b14fbd86ced