
Medical Device Compliance Expert
2 days ago
Job Overview
As a Quality Assurance Specialist, you will be responsible for ensuring the quality and compliance of medical devices in accordance with regulatory standards.
Key Responsibilities:
- Implement and maintain a Quality Management System (QMS) to ensure products meet quality, safety, and regulatory standards.
- Identify, interpret, and ensure adherence to relevant medical device regulations for market entry and ongoing compliance.
- Create, review, and control technical files, regulatory submissions, quality agreements, and internal procedures.
- Provide QA/RA input and support for design and development activities to ensure compliance from the outset.
- Participate in risk management activities throughout the product life cycle to identify and mitigate potential hazards.
- Monitor device performance in the market, investigate customer complaints and non-conformity, and manage vigilance reporting.
- Support the management of supplier quality and compliance.
- Conduct internal audits and lead initiatives to improve processes and ensure adherence to QMS requirements.
Requirements:
- Deep knowledge of global medical device regulations and standards.
- Excellent problem-solving and attention to detail skills.
- Strong communication skills to coordinate with internal departments and external stakeholders.
- Bachelor's degree in a relevant field such as engineering, life sciences, or a related technical discipline.
- Previous experience in QA/RA within the medical device industry is an advantage.
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