Regulatory Affairs Specialist/ Supervisor

Regulatory Affairs Specialist/ Supervisor

The company

I am delighted to work with a successful and growing medical device company. Providing a diverse range of capital equipment and consumable devices, my client offer a busy and dynamic environment in which to gain new skills and progress your career.

About the role

The role is ideal for someone who has strong demonstrable experience in a specialist or supervisory regulatory affairs role. Applicants must have strong experience with MDD technical file writing and approval for classes I, IIa and IIb. Candidates with 5 years+ relevant work experience will be considered.

Ongoing training will be provided where necessary.

Key responsibilities

• Line management of a team of 4 regulatory staff
• Training and progression of staff
• Ownership of regulatory output for the company
• Technical writing and review

Required experience;

• Circa 5 years+ experience in a regulatory affairs role
• Experience with medical device regulations is essential
• Class IIa and IIb experience is preferred but not essential
• Line management experience would be an advantage
• Strong leadership skills
• Excellent communication skills and a good sense of humour

Keywords:

Medical device, class, anaesthesia, critical care, surgery, regulatory affairs, RA manager, supervisor, senior, associate, lead, MDD, technical, Snr, advisor, clinical evaluation, file, implementation, team.

Harris Lord is acting as a recruitment agency for this role