
Product Compliance Manager
2 days ago
We are seeking a highly skilled Quality Assurance Specialist to excel in our team.
Job Responsibilities:- Develop and maintain a robust Quality Management System (QMS) ensuring products meet quality, safety, and regulatory standards.
- Ensure regulatory compliance by interpreting and adhering 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.
- Regulatory Expertise: In-depth knowledge of global medical device regulations and standards.
- Problem-Solving & Attention to Detail: Essential for interpreting regulations, documenting processes, and resolving issues.
- 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.
- Experience: Previous experience in QA/RA within the medical device industry is advantageous.
This role requires excellent communication skills, ability to interpret complex regulations, and experience working in the medical device industry.
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