At the heart of CSA Group is a vision: making the world a better, safer, more sustainable place. It's been part of our mission for nearly one hundred years: from the first engineering standard for railway bridges developed in 1919, to more than 3,500 standards, codes & related products today.
Headquartered in Canada, with a global footprint of more than 30 labs and offices across Europe, Asia and North America, CSA Group tests, inspects and certifies a wide range of products - from every day househould items to leading edge technology-to meet exacting requirements for safety, performance and environmental impact.
Our employees take pride in making a difference in people's lives through the work that we do. We're looking for people like you to help make it happen.
CSA Group Europe has an opportunity for a Clinical Reviewer MDR/IVDR (f/m/d) to join our Healthcare Regulatory Services Team in Germany and throughout Europe.
The Clinical Reviewer will support the MD/IVD assessment team in the delivery of clinical assessments of products under the European Regulations towards Medical and In Vitro Diagnostic Devices Regulation.
These are your duties:
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
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