Clinical Evaluator (MDR, CER Writer)

If you have hands on experience as a Clinical Evaluator or Medical Writer (CER Writer) for Medical Device industry , speak fluent English , and are curious about joining a US manufacturing brand in Wrocław - APPLY!

The Medical Writer on Clinical team provides technical writing and contributes to safety report writing. Activities include authoring Clinical Evaluation Report documents for the Consumer Health Care business, summarizing publications for physician review, and working with global regulatory teams to coordinate written materials.

what we offer

• Stable employment within an international organization with long-term career development opportunities
• Daily collaboration with a US-based team (4 FTEs) and RA (Regulatory Affairs) teams across EMEA
• Diverse product portfolio - over 47 different medical device categories to manage
• Streamlined recruitment process - only 1 stage with the client
• Flexible start date - March / April (preferred) or May / June (also possible)
• Fully remote working model
• Working hours aligned with US Central Time - ideally starting at 11 : 00 a.m. (flexible start between 9 : 00 a.m. and 11 : 00 a.m. is also possible)
• Comprehensive benefits package - private medical care (individual and family packages), group insurance (in PZU), sports card (for you and your loved ones)

your tasks

Writes and contributes to Clinical Evaluation reporting deliverables including Clinical Evaluation Plans / Reports, PMS and PMCF Plans / Reports, SSCPs, Regulatory Responses and other related documentation

Demonstrates understanding of clinical background and state of the art, literature review and accompanying search strategy, article processing (scoring, data extraction into table format, and article summaries to be synthesized, analyzed, and summarized), MAUDE search and other safety database results summary, internal clinical trial results and status updates as well as clinicaltrials.gov search and results

Ensures compliance to applicable regulations and guidance’s (ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, MDR, and EU and FDA guidance documents)

Integrates and interprets competitor data table and comparison summary, sales / complaints results and analysis, vigilance summary, risk / benefit evaluation based on provided data and the essential requirements, analysis of the device(s) claims matrix, summary including any field actions, CAPAs, recalls and explanation of mitigations therein, references, appendices, final QC and back-and forth review with MD Reviewer and Notified Bodies

what we expect

Minimum Bachelor’s degree in a Science or equivalent technical degree or an equivalent combination of education and work experience

Employment agency entry number 47

this job offer is intended for people over 18 years of age