Práca SME SME.sk
Pridať inzerát

Regulatory Affairs Coordinator

Biometrix, s. r. o.

Information about the position

  • Place of work: Vicenzy 16, Šamorín
  • Basic wage component (gross) and other rewards: 1 300 EUR/monthsalary is based on experience
  • Start date: ASAP
  • Contract type: full-time

Job description, responsibilities and duties

We are expanding our Regulatory Affairs Team! We are looking for a detail-orientated candidate, whose responsibilities will be:
- Ensure regulatory compliance of medical devices with regulations on country level and in country of delivery and executes all required regulatory activities.
- Responsibility for coordination and preparation of regulatory product notifications and registrations in given timelines.
- Contact with State Institute for Drug Control and Slovak Chamber of Commerce and Industry to register new medical products or update existing registrations.
- Provide support for preparation of Clinical Research Reports
- Preparation and update of technical files and internal documents.
- SK-EN translation of required documentation.
- Preparation and maintain of regulatory documents (declarations, summary reports, clinical evaluation, summary of relevant web search etc.) required for marketing approvals in different countries.
- Legalization of documentation and certificates via notary offices, embassies and Ministry of Foreign Affairs as necessary to obtain and sustain product approval.
- Supporting registration of customers in international markets.
- Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
- Decomposition of products in connection with exports and ensuring Certificate of Country of Origin.

Employee perks, benefits

We offer:
- Contract for indefinite duration
- Opportunity to be part of a strong and stable international company
- Professional education and continuous gaining of new experience
- Meal vouchers €5

Information about the selection process

If you are interested in this position, please send us your CV in English language. We will contact suitable candidates only. Thank you for your understanding.

Please note that together with your application for employment, you are granting us your consent to the registration and processing of personal data under Act No 18/2018 Z.z. and Regulation (EU) 2016/679.

Requirements for the employee

Candidates with education suit the position

University education (Master's degree)

Educational Specialization

Life sciences, chemistry, technical/engineering education

Language skills

English - Advanced (C1) and Slovak - Proficiency (C2)

Other knowledge

Microsoft Office - advanced

Driving licence

B

Number of years of experience

Regulatory Affairs experience, clinical or related field
2

Personality requirements and skills

Expertise in laboratory analysis, manufacturing procedures and clinical testing is advantage.
High attention to details.
Strong analytical and organizational skills.
Strong writing skills.
Strong interpersonal skills.

Advertiser

Brief description of the company

Biometrix develops, manufactures and markets innovative, high-quality medical devices for intensive care, surgery and interventional cardiology. Offering a wide range of tailored and cost-effective products, Biometrix's customers benefit from state-of-the-art solutions used in hospitals and medical centers worldwide. Our products are sold in over 50 countries worldwide.
Biometrix is part of Q Medical Devices, a Q Holding Company, which is owned by 3i.

Number of employees

150-199 employees

Company address

Biometrix, s. r. o.
Vicenzy 16/2054
931 01 Šamorín
http://www.biometrixmedical.com