Senior Regulatory Specialist, Baltics

Tallinn, Estonia

Due to organisational changes, a global medical devices company is looking to appoint a Regulatory Affairs person for the Baltic States, who will be responsible for all the aspects of regulatory activities for their products in Estonia, Latvia and Lithuania.

Company Offers

  • An attractive compensation package with benefits (company car, health insurance, performance bonus, etc.);
  • A new challenge and prospects of career progression within a growing company;
  • A high level of responsibility and independence;
  • A workplace flexibility.

Requirements

  • University degree in Life Sciences, Pharmacy or Biomedical Engineering;
  • At least 3-4 years Regulatory Affairs experience within pharmaceutical or medical technology company dealing with Medical Devices;
  • Solid knowledge of the local and EU legal regulations related to registrations of medical devices;
  • Good organisational skills and ability to work independently;
  • Fluency in Estonian/Latvian/Lithuanian and English, both written and spoken;
  • Computer literacy (Microsoft Office tools);

Main Duties & Responsibilities

  • Planning and managing regulatory submissions for new product registrations and already marketed products;
  • Ensuring portfolio maintenance in compliance with national, MRP, DCP and CP procedures;
  • Providing expert support to internal and external customers (health authorities, distributors, partners, etc.);
  • Acting as the main point of contact for all regulatory issues;
  • Reviewing labelling and promotional materials;
  • Reporting to the regional Regulatory Affairs Manager outside of Baltics.

Job Summary

Status:
This position has been filled
Posted:
3 years ago
Employment Type:
Full-time
Job Function:
Regulatory Affairs
Seniority Level:
Senior
Industry:
Medical Devices