Regulatory Compliance Specialist
3 days ago
Riverside Medical Packaging, a leading manufacturer of medical devices, is seeking a highly organized and detail-oriented Regulatory Compliance Specialist to join its Quality team. As a key member of the team, you will play a critical role in ensuring the company's compliance with quality standards, EU & UK medical device regulations, and the continued effectiveness of the Quality Management System (QMS).
Key Responsibilities:
- Assist in the upkeep and creation of Technical Files, ensuring compliance with regulatory requirements.
- Conduct thorough literary research to stay up-to-date with regulatory changes and industry developments.
- Support the team in maintaining product specifications, controlling and maintaining product specifications, and ensuring on-time fulfillment of compliance and regulatory changes.
- Maintain effective communications with EU representatives, Economic Operators, Distributors, and the Group compliance team on matters relating to compliance.
- Communicate with competent authorities on matters relating to EUDAMED, incidents, and recalls.
- Provide support with product data collection and reviews, participating in the change control process for new product introduction and alterations.
- Adhere to the Company's hygiene and quality standards (GMP) at all times, facilitating the development of an open productive culture where people take pride and responsibility in what they do.
- Embrace the culture of Environmental, Social & Governance Policy without fear of putting forward new ideas, demonstrating good employee relations within the team and to other departments.
About Riverside Medical Packaging:
Riverside Medical Packaging is part of the Sterimed Group, operating within the medical sector globally. As an ethical and environmentally responsible employer, we offer a collaborative atmosphere where you will thrive as a member of a supportive team dedicated to excellence and continuous improvement. Every team member plays a critical role in ensuring the quality and safety of products in accordance with our client's needs.
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