
Product Safety Compliance Manager
12 hours ago
Job Description:
We are seeking an experienced Quality Assurance Specialist to implement and maintain a quality management system that ensures products meet quality, safety, and regulatory standards.
The successful candidate will identify, interpret, and ensure adherence to relevant medical device regulations for market entry and ongoing compliance.
The Quality Assurance Specialist will create, review, and control technical files, regulatory submissions, quality agreements, and internal procedures.
This role will provide QA/RA input and support for design and development activities to ensure compliance from the outset.
The individual will participate in risk management activities throughout the product life cycle to identify and mitigate potential hazards.
Monitoring device performance in the market, investigating customer complaints and non-conformity, and managing vigilance reporting is also part of the job.
The Quality Assurance Specialist will also be responsible for supporting the management of supplier quality and compliance.
Additionally, this role will involve conducting internal audits and leading initiatives to improve processes and ensure adherence to QMS requirements.
- Regulatory Expertise: Deep knowledge of global medical device regulations and standards.
- Problem-Solving & Attention to Detail: Crucial 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 an advantage.
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