
Senior Regulatory Compliance Officer
2 days ago
We are seeking a detail-oriented Quality Assurance Specialist to join our team. This role will play a crucial part in ensuring that our products meet the highest quality, safety, and regulatory standards.
- Key Responsibilities:
- Implementing and maintaining a quality management system (QMS) in accordance with ISO 13485 to ensure compliance with regulatory requirements.
- 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/RA 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 non-conformity, and managing vigilance reporting.
- Supporting the management of supplier quality and compliance.
- Conducting internal audits and leading initiatives to improve processes and ensure adherence to QMS requirements.
Requirements:
- Regulatory expertise is essential, with deep knowledge of global medical device regulations and standards.
- Problem-solving skills and attention to detail are crucial for interpreting regulations, documenting processes, and resolving issues.
- Effective communication skills are necessary for coordinating with internal departments and external stakeholders.
- A Bachelor's degree in a relevant field such as engineering, life sciences, or a related technical discipline is required.
- Previous experience in QA/RA within the medical device industry is advantageous.
What We Offer:
Our company offers a stimulating work environment, opportunities for professional growth, and a competitive compensation package.
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