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

Employment Status : Regular

Time Type : Full time

BUILDING A WORLD CLASS TEAM STARTS WITH YOU

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.

Job Summary :

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.

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

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

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