Healthcare Regulatory Project Planner

vor 2 Wochen

Plattling, Bayern, Deutschland CSA Group Vollzeit

About CSA Group

CSA Group is a leading global provider of testing, inspection, and certification services for a wide range of products, including medical devices. Our mission is to make the world a better, safer, and more sustainable place.

Job Summary

We are seeking a highly skilled Regulatory Project Planner to join our Healthcare Regulatory Services Team in Germany and throughout Europe. As a key member of our team, you will be responsible for technical planning of assessments, ensuring compliance with regulatory requirements, and providing expert advice to clients.

Key Responsibilities

  • Technical evaluation of applications, including feedback to clients on completeness and plausibility
  • Planning and scheduling of assessments within the appropriate timeframe, considering all relevant technical aspects of certification programs
  • Ensuring availability of required resources for compliant performance of assessments
  • Review of clients' applications under consideration of regulatory requirements of underlying certification programs
  • Interface position to sales teams, providing technical information on offered programs and customer-specific information for cross-selling laboratory services
  • Supporting the Head of Medical Regulatory Services in establishing and implementing operation procedures for application review and project planning
  • Liaising with customers in planning stage to ensure requirements of national/international standards are met without compromising confidentiality

Requirements

  • Bachelor's degree in technical, medical, or scientific university or polytechnic studies or comparable professional knowledge
  • 4+ years of relevant experience in management system certification in the field of medical devices
  • Knowledge of global medical device conformity assessment programs (e.g., MDSAP, TCP, JPAL, HKMDACS, UKCA, FDA)
  • Knowledge of relevant regulations, directives, and guidelines for certification of MD/IVD devices (Regulations (EU) 2017/745 and 2017/746), relevant MDCGs, and the role of the Notified Body
  • Strong interpersonal skills, self-starter, good organizational skills
  • Ability to manage multiple clients and changing schedules and deadlines with supervision
  • Excellent communication skills (verbal and written)
  • Strong conflict resolution skills to handle difficult situations
  • Qualification as management system auditor in the healthcare sector is a benefit
  • Technical competence in 2 or more main technical areas (IAF MD9) is a benefit
  • Good command of German and English language skills, 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

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