Regulatory Affairs Lead

7 days ago


Fatih, Istanbul, Turkey Fresenius Medical Care Full time

About Fresenius Medical Care

We are a global leader in providing products and services for individuals with renal failure, and we're seeking a skilled Quality Assurance Supervisor to join our team.

Responsibilities

  • Spearhead Quality & Regulatory compliance efforts across the organization, ensuring alignment with business objectives.
  • Oversee Field Action activities, working closely with HQ and third-party intermediates to achieve timely resolutions.
  • Ensure timely reporting of PMS activities, including customer complaints and field actions.
  • Address customer and supplier inquiries related to product quality assurance, ensuring adherence to global procedures.
  • Maintain a robust Quality Management System, supporting ISO 13485 and ISO 9001 matrix certificate continuity.
  • Conduct comprehensive QMS and authority audits, managing CAPA processes and ensuring timely actions.
  • Foster collaboration with external auditors and regulatory agencies during audits and follow-ups.
  • Develop and implement QA audit plans in various facilities.
  • Deliver quality training to employees and manage documentation systems.
  • Monitor and improve HSE-related activities within the company.
  • Support the department in meeting Quality KPIs and implementing necessary actions.
  • Lead complex, multidisciplinary, and regional/global projects to achieve quality goals or compliance, aligned with business needs.

Essential Requirements

  • University degree, preferably in a scientific discipline.
  • Minimum 4-5 years of experience in Quality System Management in medical device and/or pharmaceutical industries.
  • Auditing experience is mandatory, with preferred auditor certifications.
  • Extensive knowledge of healthcare, medicine, and/or biomedical sectors, along with MDD/MDR regulations.
  • Fluent English language skills.
  • Proficiency in MS Office applications.
  • Superior analytical and problem-solving abilities.
  • Exceptional communication and presentation skills.
  • Excellent organizational and time-management skills.
  • Ability to collaborate, multitask, and prioritize tasks efficiently.


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