Senior Quality and Regulatory Manager
Vor 2 Tagen
We are seeking a seasoned professional to join our team at Metric Bio as a Senior Quality and Regulatory Manager. This role will be instrumental in ensuring the highest standards of quality and regulatory compliance across our operations.
About the Role
The Senior Quality and Regulatory Manager will be responsible for establishing and maintaining our Quality System requirements, collaborating with junior peers to set and achieve quality and regulatory goals, and assisting in regulatory preparations and negotiations for new markets.
Key Responsibilities
- Develop and implement quality management systems to ensure compliance with regulatory requirements.
- Collaborate with cross-functional teams to identify and mitigate quality and regulatory risks.
- Provide regulatory training and mentorship to staff across departments.
- 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.
Requirements
- Master's or MBA degree in engineering, biomedical, or related field.
- 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).
- 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.
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