Quality and Regulatory Affairs Manager (m/w/d)
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Raum München |
Permanent
Positionstitel: Quality and Regulatory Affairs Manager (m/w/d)
Anstellungsdauer: unbefristet
Branche: MedizintechnikIdealer Startzeitpunkt: ab sofort
Einsatzort: Raum München
Aufgaben:
- Ensure that applicable Quality System requirements are effectively established and maintained.
- Lead preparations and negotiations with regulatory agencies/authorities new markets while acting as a primary point of contact for regulatory authorities in existing markets.
- Ensure business teams consider the impact of current or emerging quality and regulatory issues.
- Ensure staff receives appropriate regulatory training and mentoring to enable the execution of regulatory responsibilities across various departments.
- Explain audit findings, resolve conflicts, and consult on corrective and preventative actions if issues arise.
- interface with Regulatory Agencies during inspections.
- Represent the organisation during regulatory and client inspections/audits.
- Prepare site/operation personnel for regulatory audits and prepare appropriate summaries and reports of such audits.
- Track corrective actions and apprise management of their status.
- Perform general auditing duties for compliance with quality standards.
- Be responsible for the final review and management of SOPs and QM-related documents.
- Assist with Vendor Assessment, client audits and subcontractor audits.
Qualifikationen:
- Degree in engineering, bio medical or similar would be necessary, Masters degree or MBA is considered a plus.
- 5+ years of relevant experience in quality management and regulatory affairs for medical devices.
- Specialist knowledge of ISO 13485 and medical device regulations is mandatory.
- Experience in managing external audits with notified bodies and competent authorities as per ISO 13485 & MDR.
- Experience in risk management of medical devices as per ISO 14971.
- Fluency in English and B2 level of German is required.
- Flexible, goal oriented and a team player would be an ideal candidate.
Referenznummer: 13822
Branche: Medizintechnik
Beginn des Projekts: ab sofort
Dauer: n. A.
Anstellungsart: Permanent
Kontakt
Silke Tauber