Senior Quality and Regulatory Manager
vor 2 Wochen
We are partnering with a German based growing MedTech business focusing on the treatment of Skin Cancer. Our client is seeking a Senior Quality and Regulatory Manager with a strong background in quality management and regulatory affairs.
About the job
Senior Quality and Regulatory Manager
Munich, Germany
To be successful have a proven ability to collaborate with internal stakeholders, mentor junior peers, and manage external resources such as consultants and advisors.
- Establish and maintain Quality System requirements.
- Collaborate with junior peers to set and achieve quality and regulatory goals.
- Assist in regulatory preparations and negotiations for new markets; act as a contact for regulatory authorities in existing markets.
- Advise business teams on emerging quality and regulatory issues.
- Provide regulatory training and mentorship to staff across departments.
- Explain audit findings, resolve conflicts, and consult on corrective actions.
- Interface with Regulatory Agencies during inspections and audits.
- Represent the organization during client and regulatory audits.
- Prepare and guide site personnel for regulatory audits and compile audit reports.
- Track and report on corrective actions.
- Manage and review SOPs, QM-related documents, and Technical Documentation.
- Support Vendor Assessment, client audits, and subcontractor audits.
- Optimize Quality and Regulatory processes and ensure global QA/RA compliance.
Required Qualifications
- Degree in engineering, biomedical, or related field; Master’s or MBA is a plus.
- 4+ years of experience in quality management and regulatory affairs for medical devices.
- Experience with submissions, technical documentation, and approval processes (MDD/MDR/De Novo/510(k)).
- In-depth knowledge of medical device QMS (ISO 13485 / 21 CFR 820).
- Experience managing external audits with notified bodies and competent authorities.
- Proficiency in medical device risk management (ISO 14971).
- Familiarity with standards for electrical testing, EMC testing (ISO 60601), or ISO 62366 series, and Post Market Surveillance.
- Strong coaching and mentoring skills.
- Fluent in English
Sounds like a fit? Click apply.
Please note, you will only be considered if you have the required experience listed.
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