Regulatory Affairs Specialist

A company is looking for a Regulatory Affairs Specialist.

Key Responsibilities

Coordinate and prepare document packages for regulatory submissions and internal audits

Lead the compilation of materials for submissions, license renewals, and annual registrations

Monitor regulatory compliance and recommend changes for labeling, manufacturing, and clinical protocols

Required Qualifications

Bachelor's degree required

3-5 years of relevant experience in regulatory affairs

Experience with EU regulations (AIMDD & EU MDR) and ISO 13485

Ability to interact with Notified Bodies and Competent Authorities

Practical knowledge and demonstrated competence in the regulatory field