SLE is a world leader in the design and manufacture of neonatal ventilators and related products with a strong international reputation.
REGULATORY AFFAIRS SPECIALIST
A great new opportunity has been created for an experienced Regulatory Affairs Specialist who will assist with the management of regulatory affairs and deputise for the Regulatory Affairs Manager, as necessary.
Working closely with the quality assurance and design teams you will have good knowledge of worldwide regulatory standards and demonstrable experience of ISO13485, CE marking, technical file submissions and of driving regulatory processes and activities.
There will be an initial focus on providing a gap analysis against our current product portfolio and developing remediation plans to meet current medical device requirements.
A BSc or MSc degree within an engineering, design, medical or sciences background or equivalent experience
- Demonstrated Regulatory experience in active Class IIb and III medical devices
- Experience dealing directly with Notified Bodies, Competent Authorities and MHRA
- Hands on experience of creating compliance documentation
- Knowledge of compliance with key international standards such as ISO 13485, ISO 14971
- Excellent communication skills
- Strong organisational skills, including the ability to prioritise workload
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, manufacturing and commercial
- Competitive salary
- Up to 10% discretionary performance related bonus
- Contributory pension scheme and life assurance
- Flexible working options
- Training and development opportunities
To apply please send your CV and cover letter to: firstname.lastname@example.org
Closing Date: 31 March
No Agencies please