Regulatory Compliance Specialist
1 month ago
Riverside Medical Packaging, a leading manufacturer of medical devices, is seeking a highly organized and detail-oriented Regulatory Officer to join our Quality team. As a Regulatory Officer, you will play a critical role in maintaining our company's compliance with quality standards, EU & UK medical device regulations, and supporting the effectiveness of our 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 timely fulfillment of compliance and regulatory changes, ensuring minimal disruption to our operations.
- Control and maintain product specifications, ensuring accuracy and consistency.
- Maintain effective communication 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, ensuring data accuracy and integrity.
- Participate in the change control process for new product introduction and alterations, ensuring seamless implementation.
- Adhere to the Company's hygiene and quality standards (GMP) at all times, promoting a culture of excellence.
- Foster an open and productive culture where team members take pride and responsibility in their work.
- Embody the company's Environmental, Social & Governance Policy, encouraging innovation and continuous improvement.
- Demonstrate excellent employee relations within the team and with other departments, promoting a positive work environment.
About Riverside Medical Packaging:
Riverside Medical Packaging is part of the Sterimed Group, operating globally in the medical sector. We pride ourselves on being an ethical and environmentally responsible employer, offering 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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