Senior Regulatory Specialist, Baltics
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.); […]
Job Description
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.