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Clinical Evaluation Specialist
For a globally known manufacturer of high-quality disposable medical equipment for hospitals and home care, we are searching for a Clinical Evaluation Specialist.
The purpose of this job is to author and develop clinical evaluation reports(CERs) per MEDDEV 2.7.1 Rev 4 and MDR regulations (MDCG 2020-6) to meet essential requirements in support of submission for CE Mark application to obtain Declaration of Conformity and EU market clearance, recertification and proposed indication/labeling changes, as well as CER updates to maintain EU product conformance. The person will develop and review Post Market Clinical Follow-up (PMCF) strategies and participate in Risk Management assessments and Post market surveillance (PMS).
Lead and/or participate in the conduct of evaluation studies, including complex evaluations like the annual evaluation review. Draw lessons from evaluation studies and their implications for improving development effectiveness.
The role holder will be involved in the overall continuous improvement activities of the clinical affairs department including document and process gap analysis, ensuring compliance with changing regulations, maintaining, and updating of relevant SOP’s, templates, documents, and archives.
KEY ACCOUNTABILITIES AND RESPONSIBILITIES
- Writing of Clinical Evaluation Plans and Reports according to current European Medical Device Regulations
- Reviewing, structuring, and revising existing Medical Device Clinical Evaluation Documents (Life Cycle Management)
- Systematic literature searches in appropriate data bases and documentation
- Proactive cooperation with Product Management and Development and other internal departments
- within the company to ensure smooth clinical evaluation process of medical devices
- Developing and reviewing Post Market Clinical Follow-up (PMCF) strategies
- Participating in Risk Management assessments and Post market surveillance (PMS)
- Enforce compliance to regulations and internal processes to adhere to the new Medical Device Regulations (MDR) standards
- Transferring of knowledge on Medical Device Regulations standards documentation into organization
- The role holder will perform all tasks in accordance with JSOX and ISO quality requirements and taking the company’s values into account.
WHAT THE COMPANY OFFERS
- A job in a dynamic international environment
- Training and self-development opportunities
- Preferentially a Master in a Bio-Scientific or Medical discipline or Bio-engineer or Bio-medical engineer
- 3-5 years of professional experience in systematic literature searching, and experience with relevant databases such as Embase and Medline and clinical studies.
- 3-5 years of previous experience in medical writing with RA or clinical evaluation background
- Previous experience in working with international (global) teams
- Excellent written and verbal communication skills in English
- Excellent command of MS Office applications
- Previous experience in medical device or Renal care industry is a plus
- Systematic, structured, efficient, and goals -oriented working style
- Can-do attitude, excellent communication skills, very dynamic and agile team player