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.
- 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.
- 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.