Regulatory Affairs Lead
7 days ago
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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