Regulatory Officer

Robertson Recruitment Services Ltd

Posted 18 hours ago, valid for a month

Derby, Derbyshire DE12FU, England

£30,000 per annum

Full Time

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Sonic Summary

We are seeking a Regulatory Officer for our medical client based in Derby, with a salary of £35,000 to £45,000 per year.
The role requires maintaining compliance with ISO13485, UK and European Medical Device Regulations, and US FDA Regulations 21CFR part 820.
Candidates should have relevant QMS/Regulatory qualifications and a minimum of 2-3 years of experience in the medical manufacturing industry.
Key responsibilities include assisting with Technical Files, supporting product data collection, and maintaining relationships with customers and competent authorities.
Benefits include a company pension, quarterly and yearly bonuses, on-site parking, and a cycle-to-work scheme.

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

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