Healthcare Regulatory Project Planner
vor 2 Wochen
CSA Group is seeking a highly skilled Healthcare Regulatory Project Planner to join our team in Germany and throughout Europe.
Job Summary:The successful candidate will be responsible for technical planning of assessments based on the understanding of information from clients' applications. This includes evaluating applications, ensuring assessments are planned and scheduled within the appropriate timeframe, and ensuring all required resources are available.
Key Responsibilities:- Evaluate client applications and provide feedback on completeness and plausibility
- Plan and schedule assessments within the appropriate timeframe, considering technical aspects of certification programs
- Ensure all required resources are available for compliant assessment performance
- Review clients' applications under consideration of regulatory requirements
- Interface with sales teams to provide technical information on offered programs and customer-specific information
- Support the Head of Medical Regulatory Services in establishing and implementing operation procedures
- Plan, prepare, and demonstrate contents for auditor experience exchange and technical training events
- Liaise with customers to ensure requirements of national/international standards are met without compromising confidentiality
- 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
- Knowledge of relevant regulations, directives, and guidelines for certification of MD/IVD devices
- Strong interpersonal skills, self-starter, good organizational skills
- Ability to manage multiple clients and changing schedules and deadlines
- Excellent communication skills (verbal and written)
- Strong conflict resolution skills
- 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)
- 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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