Regulatory Compliance Specialist
2 months ago
About Riverside Medical Packaging Company Ltd:
Riverside Medical Packaging Company Ltd is a leading manufacturer of medical devices, specializing in developing innovative solutions to meet the demanding requirements of the medical industry. Our state-of-the-art manufacturing facility is equipped with the latest technology and is accredited to BSI/ISO standards.
Job Summary:
We are seeking a highly organized and detail-oriented Regulatory Compliance Specialist to join our Quality team. The successful candidate will assist in maintaining the company's compliance to quality standards, EU & UK medical device regulations, and support the effectiveness of the Quality Management System (QMS).
Key Responsibilities:
- Assist in the upkeep and creation of Technical Files, ensuring compliance with regulatory requirements.
- Conduct literary research to stay up-to-date with regulatory changes and industry developments.
- Support the on-time fulfillment of compliance and regulatory changes, ensuring minimal disruption to business operations.
- Control and maintain product specifications, ensuring accuracy and consistency.
- 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, ensuring data accuracy and integrity.
- Participate in the change control process for new product introduction and alterations, ensuring compliance with regulatory requirements.
- Adhere to the Company's hygiene and quality standards (GMP) at all times.
- 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.
Why Choose Riverside Medical Packaging Company Ltd:
Riverside Medical Packaging Company Ltd is a collaborative and supportive employer, dedicated to excellence and continuous improvement. We offer a dynamic work environment where team members can thrive and contribute to the success of the company.
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