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Clinical Affairs Coordinator
Biometrix, s. r. o.
Place of work
Vicenzy 16, Šamorín
Vicenzy 16, Šamorín
Contract type
full-time
full-time
Start date
ASAP
ASAP
Wage (gross)
From 1 300 EUR/monthsalary is based on experience
From 1 300 EUR/monthsalary is based on experience
Information about the position
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.
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
- 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
Medical writing is an advantage.
High attention to details.
Strong analytical and organizational skills.
Strong writing skills.
Strong interpersonal skills.
Fluent English
Advertiser
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
150-199 employees
ID: 4238454
Dátum zverejnenia: 14.1.2022
2022-01-14
lokalita: Šamorín Pozícia: Administrative Worker, Official, Clinical Research Associate, Regulatory Affairs Specialist Spoločnosť: Biometrix, s. r. o.
Základná zložka mzdy (brutto): 1 300 EUR/month