Clinical Evaluation Specialist MDR/IVDR

vor 1 Monat

Plattling, Bayern, Deutschland CSA Group Vollzeit

Employment Status:

Permanent

Time Type:

Full-time

BUILDING A WORLD CLASS TEAM STARTS WITH YOU

At CSA Group, we are driven by a vision of creating a better, safer, and more sustainable world. This mission has been our guiding principle for nearly a century, evolving from the establishment of the first engineering standard for railway bridges in 1919 to the development of over 3,500 standards, codes, and related products today.

With our headquarters in Canada and a global presence that includes more than 30 laboratories and offices across Europe, Asia, and North America, CSA Group is dedicated to testing, inspecting, and certifying a diverse array of products—from everyday household items to cutting-edge technologies—to meet stringent safety, performance, and environmental standards.

Our team members take pride in making a significant impact on people's lives through our work. We are seeking individuals who share this commitment to excellence.

Job Summary:

CSA Group Europe has an opening for a Clinical Reviewer MDR/IVDR (f/m/d) to become a vital part of our Healthcare Regulatory Services Team across Europe. The Clinical Reviewer will play a crucial role in supporting the MD/IVD assessment team by delivering comprehensive clinical evaluations of products in accordance with European Regulations for Medical and In Vitro Diagnostic Devices.

  • Ensure that evaluations conducted thoroughly address the regulatory obligations of manufacturers regarding product clinical performance, aligning with contemporary expectations and justifying the risk/benefit ratio of the product. The Clinical Reviewer is expected to develop, maintain, and enhance clinical assessment procedures and protocols in accordance with CSA Group and external authority standards.
  • Responsible for creating and delivering up-to-date training for clinical assessors and organizing regular calibration events for the clinical team.
  • Assist the Head of Medical Regulatory Services in demonstrating to relevant authorities that effective clinical assessment procedures and protocols are established and that clinical assessment projects are executed and reviewed in line with CSA Group protocols.
  • Oversee and review clinical data assessments conducted by other clinical staff (both internal and external) to ensure compliance with applicable National and International Regulations and Standards.
  • Collaborate with the Commercial team to assist in the formulation and estimation of efforts for clinical assessments of products as required.
  • Represent CSA Group by actively participating as a speaker at conferences on technical and clinical topics.

Qualifications:

  • University degree in medical or scientific disciplines or equivalent professional expertise.
  • A minimum of 5 years of relevant clinical experience.
  • In-depth knowledge of the applicable regulations, directives, and guidelines for the certification of MD/IVD devices (Regulations (EU) 2017/745 and 2017/746), relevant MDCGs, and the role of Notified Bodies.
  • Extensive experience in evaluating and making decisions regarding medical and/or IV devices under conformity assessment procedures.
  • Strong interpersonal skills, self-motivated, with excellent decision-making and organizational abilities.
  • Capacity to manage multiple clinical evaluations and adapt to changing schedules and deadlines with minimal supervision.
  • Exceptional communication skills, both verbal and written.
  • Strong conflict resolution skills to effectively navigate challenging situations.
  • Proficiency in both German and English, with additional European languages being an advantage.

Enjoy a flat organizational structure in a professional and multicultural corporate environment, with opportunities for remote work and flexible hours. Engage in stimulating tasks, exciting projects, and the chance to contribute your innovative ideas. Benefit from wellness programs to maintain a balanced work-life routine, a bike leasing program, a company pension plan, and various corporate benefits, along with opportunities for continuous training and development.

This is a permanent position.

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