Job Description
Regulatory Officer
We are looking for a regulatory officer for our medical client based in Derby. To assist with maintaining the company's compliance to ISO13485, European and UK Medical Device Directives/Regulations and US FDA Regulations 21CFR part 820. You will also be asked to support the continued effectiveness of the Quality Management System.
Regulatory Officerworking hours
Monday to Friday - 08:00 - 16:30pm (can be flexible with start times/finishes)
Regulatory Officer duties
* Assisting with the upkeep and creation of Technical Files
* Provide support with product data collection and reviews
* Assist with on-time fulfilment of compliance and regulatory changes
* Control and maintain product specifications
* Maintain relationships with customers
* Communicate with competent authorities on matters relating to new products, incidents and recalls.
* Participate with the change control process for new product introduction and alterations.
Regulatory Officer skills
* Have relevant QMS/Regulatory educational and training qualifications
* Experience and understanding of Quality Management systems and Medical Device regulations
* Strong analytical and literacy skills
* Previous experience in working in the medical manufacturing industry would be advantageous
* Excellent planning, communication and organisational skills
* Good computer skills
Regulatory Officer benefits
* Company pension
* Company events
* Quarterly bonus
* Yearly bonus
* On site parking
* Cycle to work scheme
Please contact Dan on 07464 733898 if you are interested in this role
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