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 safety, sustainability, and quality of life globally. For nearly a century, we have been at the forefront of developing standards that ensure products meet rigorous safety and performance criteria.

With our headquarters in Canada and a robust presence across Europe, Asia, and North America, CSA Group is dedicated to testing, inspecting, and certifying a diverse array of products—from everyday items to cutting-edge technologies—ensuring they comply with stringent safety 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.

Position Overview:

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

  • Ensure thorough assessments that address the manufacturer's regulatory obligations regarding product clinical performance, aligning with current industry standards and justifying the risk/benefit ratio for the product.
  • Develop and deliver comprehensive training for clinical assessors and facilitate regular calibration sessions for the clinical team.
  • Assist the Head of Medical Regulatory Services in demonstrating compliance with established clinical assessment protocols to relevant authorities.
  • Oversee and review clinical data evaluations conducted by both internal and external clinical staff to ensure adherence to applicable national and international regulations.
  • Collaborate with the Commercial team to estimate efforts for clinical assessments as required.
  • Represent CSA Group at industry congresses, delivering presentations on technical and clinical topics.

Qualifications:

  • A university degree in a medical or scientific discipline or equivalent professional experience.
  • A minimum of 5 years of relevant clinical experience.
  • In-depth knowledge of regulations, directives, and guidelines for the certification of MD/IVD devices, including EU Regulations 2017/745 and 2017/746.
  • Extensive experience in evaluating and making decisions regarding medical and/or IV devices within conformity assessment frameworks.
  • Strong interpersonal, decision-making, and organizational skills.
  • Ability to manage multiple clinical evaluations and adapt to changing schedules and deadlines.
  • Excellent verbal and written communication skills.
  • Proficient conflict resolution skills to navigate challenging situations.
  • Proficiency in both German and English, with additional European languages considered an asset.

Work Environment:

  • Flat hierarchies in a professional and multicultural corporate setting.
  • Flexible working hours and the option to work remotely.
  • Engaging projects and the opportunity to contribute innovative ideas.
  • Wellness programs to promote a balanced work-life experience.
  • Access to a bike leasing program.
  • Company pension plan and additional corporate benefits.
  • Continuous training and learning opportunities.

Employment Type:

Permanent

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