
Medical Device Regulatory Compliance Specialist
1 day ago
Quality Assurance Position
We are seeking a highly skilled Quality Assurance professional with expertise in global medical device regulations and standards.
Key Responsibilities:
- Implementing and maintaining a Quality Management System to ensure compliance with regulatory standards.
- Identifying, interpreting, and ensuring adherence to relevant medical device regulations for market entry and ongoing compliance.
- Creating, reviewing, and controlling technical files, regulatory submissions, quality agreements, and internal procedures.
- Providing QA input and support for design and development activities to ensure compliance from the outset.
- Participating 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 managing vigilance reporting.
- Supporting supplier quality and compliance management.
- Conducting internal audits and leading initiatives to improve processes and ensure adherence to QMS requirements.
Requirements:
- Regulatory expertise: Deep knowledge of global medical device regulations and standards.
- Problem-solving skills: Crucial for interpreting regulations, documenting processes, and resolving issues.
- Effective communication skills: To coordinate with departments and stakeholders.
- Education: Bachelor's degree in a relevant field such as engineering or life sciences.
- Experience: Previous experience in QA within the medical device industry is an advantage.
What We Offer
A supportive work environment, opportunities for growth and development, and a competitive compensation package.
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