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