Clinical Reviewer MDR/IVDR (f/m/d)

• To ensure that assessments conducted have properly examined and addressed the regulatory responsibilities of the manufacturer with respect to product clinical performance including alignment with state-of-the-art expectations and defended risk/benefit for the product. In this responsibility the CR is expected to formulate, maintain and improve clinical assessment procedures and protocols in line with both CSA Group and external Authority expectations 

• Responsible for developing and delivering up to date training to clinical assessors as well as running periodic calibration events for the clinical team 

• Support the Head of Medical Regulatory Services in demonstrating to the relevant authorities that appropriate clinical assessment procedures and protocols are in place and effective and that clinical assessment projects have been conducted and reviewed according to CSA Group procedures 

• Provide oversight and review of clinical data assessments performed by other deployed clinical staff (internal and external) in relation to customer compliance with relevant National and International Regulations and Norms

• Support the Commercial team in the formulation and effort estimation for the clinical assessments of product on an as needed basis

• Represent CSA by actively participating in congresses as speaker in regards of technical/clinical subjects 

 
What we expect: 

• University degree in medical or scientific university or polytechnic studies; or comparable professional knowledge 

• 5+ years of relevant clinical experience

• Profound knowledge of the relevant regulations, directives and guidelines for certification of MD/IVD devices (Regulations (EU) 2017/745 and2017/746), relevant MDCGs as well as the role of the Notified Body

• Multiple years of experience in the field of evaluation and decision making for medical and/or IV devices under conformity assessment procedures

• Strong interpersonal skills; self-starter; good decision-making skills and organizational skills

• Ability to manage multiple clinical evaluations and changing schedules and deadlines with supervision

• Excellent communication skills (verbal and written)

• Strong conflict resolution skills to be able to handle difficult situations

• Good command in German and English language skill written and oral. Any other European language beside German and English will be a benefit

What we offer:

• Flat hierarchies in a professional and intercultural corporate environment

• Opportunity to work from home and flexible working hours

• Attractive tasks, exciting projects and the opportunity to contribute your own ideas

• Fitness and health program for a relaxed balance to the daily work routine

• Lease a Bike

• Company pension plan

• Other Corporate Benefits

• Opportunities for constant training/learning

• Permanent employment