Regulatory Officer Job Advert
About Riverside Medical Packaging (Part of Sterimed Group): Riverside Medical Packaging specialises in developing intelligent and innovative solutions to satisfy the demanding requirements for producing, packaging and sterilising single-use medical devices. Riverside’s state-of-the-art 86,000 sq ft manufacturing facility has been tailor-made specifically for the manufacture of medical packaging and products for the medical industry’s leading clients. These superb manufacturing cells, BSI/ISO accreditation and creative R&D team enable us to provide a diverse, innovative range of high-performance products at an economical price – regardless of quantity. Built on a foundation of excellence and traceability, our success can be measured through our repeat and growing customer business.
Job Type:
* Full-time Permanent
* Office based (primarily)
* Quarterly Bonus
* Yearly Bonus
* Monday to Friday (40 hours per week)
Regulatory Officer
We have an exciting opportunity for an organised team player with excellent communication and planning skills to join our friendly Quality team. The role of Regulatory Officer will see you assisting with maintaining the company’s compliance to quality standards, EU & UK medical device regulations and supporting the continued effectiveness of the Quality Management System (QMS). The successful candidate should have knowledge and experience with Technical files, including the required content and creation. Ideally, you will also have experience with QMS, but this is not essential. You must have strong analytical and literacy skills with a positive attitude and be prepared to fulfil literary research. Previous experience in the medical manufacturing industry would be advantageous; however, transferable skills and a willingness to learn will also be taken into consideration.
What you will be doing as a Regulatory Officer:
* Assisting with the upkeep and creation of Technical Files.
* Conducting literary research.
* Assisting with on-time fulfilment of compliance and regulatory changes.
* Controlling and maintaining product specifications.
* Maintaining effective communications with EU representatives, Economic Operators, Distributors, and the Group compliance team on matters relating to compliance.
* Communicating with competent authorities on matters relating to EUDAMED, incidents, and recalls.
* Providing support with product data collection and reviews.
* Participating in the change control process for new product introduction and alterations.
* Adhering 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.
* Embracing 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.
Why choose Riverside:
Riverside Medical Packaging is part of the Sterimed Group, which operates within the medical sector all around the world. As well as priding itself on being an ethical and environmentally responsible employer, Riverside offers 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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