Healthcare Regulatory Project Coordinator

vor 2 Wochen

Plattling, Bayern, Deutschland CSA Group Vollzeit

Job Summary:

CSA Group is seeking a highly skilled Regulatory Project Planner to join our Healthcare Regulatory Services Team in Germany and throughout Europe.

The successful candidate will be responsible for technical planning of assessments based on the understanding of information from clients' applications.

Key Responsibilities:

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

Requirements:

  • Bachelor 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 besides 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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