Senior Quality and Regulatory Affairs Manager
Metric Bio
Germany
We are partnering with a fast-growing MedTech startup focused on developing innovative treatments for non-melanoma skin cancer (NMSC).
Our client is seeking a Senior Quality and Regulatory Affairs Manager to support their mission of providing non-invasive, painless, and effective care for patients.
About the Job
Senior Quality and Regulatory Affairs Manager
Munich, Germany
To succeed in this role, you should be skilled in collaborating with internal stakeholders, mentoring junior peers, and managing external resources such as consultants and advisors.
- Establish and maintain Quality System requirements to ensure compliance.
- Collaborate closely with junior peers to set and achieve quality and regulatory objectives.
- Assist in regulatory preparations and negotiations for new market entries, while acting as a contact for regulatory authorities in existing markets, specifically Europe, Australia, South Africa, and upcoming US expansion.
- Guide business teams on emerging quality and regulatory issues.
- Provide training and mentorship on regulatory requirements across departments.
- Explain audit findings, resolve conflicts, and advise on corrective and preventative actions.
- Interface with regulatory agencies during inspections.
- Represent the organization during regulatory and client audits.
- Prepare site personnel for regulatory audits and compile audit summaries and reports.
- Track corrective actions and update management on progress.
- Assist with the management and review of SOPs, QM-related documents, and technical documentation.
- Support vendor assessment, client audits, and subcontractor audits.
- Optimize quality and regulatory processes to ensure global QA / RA compliance.
Required Qualifications
- Degree in engineering, biomedical sciences, or a related field; a Master’s degree or MBA is a plus.
- 4+ years of experience in quality management and regulatory affairs for medical devices.
- Experience handling submissions, technical documentation, and the approval process (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 the ISO 62366 series, as well as post-market surveillance.
Sounds like a fit? Click apply.
Please note, only candidates with the required experience will be considered.
Vor 4 Stunden