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Healthcare Regulatory Program Manager MDSAP/ISO 13485

vor 2 Monaten

Plattling, Bayern, Deutschland CSA Group Vollzeit

Job Summary:

CSA Group is seeking a highly skilled Healthcare Regulatory Program Manager to join our team in Germany and throughout Europe. As a key member of our Healthcare Regulatory Services Team, you will be responsible for implementing and maintaining procedures for high-quality certification services that meet clients' needs in the most efficient and effective manner possible.

Key Responsibilities:

  • Provide oversight and review of certification applications, audit cycle plannings, and related assessments conducted by other deployed assessment staff (internal and external) to ensure customer compliance with relevant National and International Regulations and Standards.
  • Ensure that assessments adequately address the regulatory responsibilities of the manufacturer regarding product safety and performance, aligning with state-of-the-art expectations.
  • Formulate, maintain, and enhance assessment procedures and protocols in alignment with both CSA Group and external Authority expectations.
  • Develop and deliver updated training to assessors, as well as conduct periodic calibration events for the assessment team.
  • Demonstrate to relevant authorities that appropriate assessment procedures and protocols are effective, and clinical assessment projects have been conducted and reviewed according to CSA Group procedures.
  • Identify, select, and evaluate internal and external technical and clinical staff.
  • Represent CSA by actively participating in congresses as a speaker on technical subjects.
  • Manage certification projects concurrently, ensuring compliance with all applicable safety requirements and achieving completion within specified time frames and cost deadlines.
  • Provide client assistance in problem-solving without disclosing proprietary information.
  • Handle a diverse range of projects, including complex ones generating high revenue levels.
  • Deliver assigned projects within agreed-upon timescales consistently.
  • Demonstrate the ability to accurately manage project costs within the agreed budget.
  • Maintain good productivity in line with company expectations.
  • Demonstrate technical competence to review the work of others per divisional quality documents.

Requirements:

  • University degree in technical, medical, or scientific university or polytechnic studies; or
  • Engineering Technology or Associates Degree with 5 years industry-related experience
  • 5+ years of relevant experience in management system certification in the field of medical devices, preferably at an MDSAP Recognized AO for Medical Devices and/or IVD
  • Profound knowledge of the relevant regulations, directives, and guidelines for certification of MD/IVD devices under MDSAP as well as the role of the AO
  • Profound knowledge of global medical device conformity assessment programs (e.g., EU MDR/IVDR, MDSAP, TCP, JPAL, HKMDACS, UKCA, FDA)
  • Multiple years of experience in the field of evaluation and decision making for medical and/or IV devices under regulatory conformity assessment procedures
  • Strong communication and conflict resolution skills.
  • Technical competence to assess and evaluate QMSs under MDSAP.
  • Ability to manage multiple assessments and changing schedules and deadlines with supervision
  • Demonstrates technical competence to review the work of others per divisional quality documents
  • Demonstrates technical competence to perform witness auditing and mentoring per divisional quality documents
  • Demonstrates technical competence in 2 or more MD/IVD technical scopes
  • Excellent communication skills (verbal and written)
  • Strong conflict resolution skills to be able to handle difficult situations
  • Fluent in German and English, with proficiency in other European languages being advantageous
  • Ability to travel as needed (up to 15% travel)

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
  • Opportunities for constant training/learning
  • Permanent employment