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Clinical Affairs Coordinator

Biometrix, s. r. o.

Information about the position

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

Job description, responsibilities and duties

We are offering an interesting new opportunity in Clinical Affairs!

We are looking for a detail-orientated candidate, whose responsibilities will be:
- Responsibility for coordination and preparation of clinical product notifications and registrations in given timelines.
- Ensure regulatory compliance of medical devices with regulations on country level and in country of delivery and executes all required regulatory activities.
- Prepare and maintain of clinical/regulatory documents required for Clinical Evaluation Report and Technical Documentation
- Preparation of clinical literature search overview protocol and report
- Preparation of Clinical Evaluation Plan, Clinical Evaluation Report (CER) based on literature search report
- Working with Post Market Surveillance (PMS) team to meet the requirements in generating PMS and CER related reports
- Assisting with Risk Management File Maintenance, as necessary
- Maintain the PMCF Survey database
- Supporting analysis and interpret clinical and PMCF data
- Clinical/Regulatory support to marketing and engineering departments
- SK-EN translation of required documentation.

Employee perks, benefits

We offer:
- Opportunity to be part of a strong and stable international company producing medical devices
- 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.

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

Experience in the position/sector

Clinical Affairs/Regulatory Affairs experience, clinical or related field

Number of years of experience

2

Personality requirements and skills

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

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Brief description of the company

Biometrix as part of QMD, 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, our customers benefit from state-of-the-art solutions used in hospitals and medical centers worldwide. Our products are sold in over 50 countries worldwide.

Number of employees

100-149 employees