Clinical Assessment 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 to enhance global safety, sustainability, and quality of life. For nearly a century, we have been at the forefront of establishing standards, evolving from our first engineering standard for railway bridges in 1919 to over 3,500 standards and related products today.

With our headquarters in Canada and a presence in over 30 laboratories and offices across Europe, Asia, and North America, CSA Group is dedicated to testing, inspecting, and certifying a diverse array of products, ensuring they meet stringent safety, performance, and environmental standards.

Our team members take pride in their contributions to improving lives through our work. We are seeking individuals who share this commitment.

Job Overview:

CSA Group Europe is looking for a Clinical Reviewer MDR/IVDR (f/m/d) to enhance our Healthcare Regulatory Services Team across Europe. The Clinical Reviewer will play a crucial role in supporting the MD/IVD assessment team by conducting clinical evaluations of products in accordance with European regulations governing Medical and In Vitro Diagnostic Devices.

  • Ensure that evaluations thoroughly assess the manufacturer's regulatory obligations regarding product clinical performance, aligning with current industry standards and justifying the risk/benefit ratio for the product. The Clinical Reviewer is expected to develop, maintain, and enhance clinical assessment protocols in compliance with CSA Group and external authority standards.
  • Responsible for creating and delivering updated training for clinical assessors and organizing regular calibration sessions for the clinical team.
  • Assist the Head of Medical Regulatory Services in demonstrating to relevant authorities that effective clinical assessment protocols are in place and that projects are conducted in accordance with CSA Group procedures.
  • Oversee and review clinical data assessments performed by both internal and external clinical staff to ensure compliance with applicable national and international regulations.
  • Collaborate with the Commercial team to estimate efforts and formulate clinical assessments for products as needed.
  • Represent CSA Group by actively participating as a speaker at conferences on technical and clinical topics.

Qualifications:

  • University degree in medical or scientific fields or equivalent professional experience.
  • A minimum of 5 years of relevant clinical experience.
  • In-depth knowledge of the regulations, directives, and guidelines for the certification of MD/IVD devices (Regulations (EU) 2017/745 and 2017/746), including 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, decision-making, and organizational skills.
  • Ability to manage multiple clinical evaluations and adapt to changing schedules and deadlines with minimal supervision.
  • Excellent verbal and written communication skills.
  • Strong conflict resolution abilities to navigate challenging situations.
  • Proficiency in both German and English, with additional European languages being advantageous.

Benefits:

  • Flat hierarchies in a professional and multicultural corporate environment.
  • Flexible working hours and the option to work from home.
  • Engaging tasks, exciting projects, and the opportunity to contribute innovative ideas.
  • Fitness and health programs to promote a balanced work routine.
  • Company pension plan and other corporate benefits.
  • Continuous training and learning opportunities.
  • Permanent employment.

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