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Regulatory Affairs Specialist

2 tygodni temu

Warszawa, Mazovia, Polska SGS Pełny etat

About Us:

SGS is a world leader in testing, inspection, and certification, offering a diverse range of services to help businesses succeed. Our team of experts works tirelessly to ensure that our clients receive the highest level of service and support.

Role Description:

We are seeking a highly skilled and experienced Medical Devices Lead Auditor & Training Specialist to join our Global Medical Device team. This exciting opportunity involves dual responsibilities as a Lead Auditor and Training Specialist/Facilitator, playing a crucial role in developing and delivering auditor training materials, evaluating and approving trainee audits, and ensuring compliance with SGS procedures and regulatory requirements.

Main Responsibilities:

  • Develop and deliver auditor training materials, ensuring they meet global business scope requirements
  • Evaluate and approve trainee audits, providing formal and informal feedback on trainee performance
  • Ensure compliance with SGS procedures and regulatory requirements, maintaining auditor qualifications and supporting planning and conducting management system audits
  • Act as a mentor to junior colleagues, providing guidance and support as needed
  • Prepare and maintain core training courses, conduct peer reviews and assessments, and maintain up-to-date knowledge of relevant medical device regulations
  • Support external training activities, including administrative support

Key Qualifications:

  • Essential: Full knowledge of EUMDR 2017/745, previous auditing experience within an MDR notified body, university degree or equivalent qualification in relevant sciences, general expertise including risk management, usability, biocompatibility, clinical standards, and guidance documents relevant to medical devices
  • Desirable: Knowledge of EU IVDR 20017/746, appointed lead auditor by Notified Body under ISO 13485, MDR, IVDR, UKCA within the last 3 years, working knowledge in IVR/IVS codes for IVDR as per LPMDR.IVDR700, meeting prerequisite per LPMDREG7048 section 3 as Level 1 auditor