Regulatory Affairs Specialist - NPI (Onsite UK)

CooperCompanies; Eastleigh; On-site; GBP 60,000 - 80,000; Full time

Job summary

A renowned optical company in Eastleigh is seeking a Regulatory Affairs Specialist to manage regulatory strategies for new products. The ideal candidate will have over five years of experience in regulatory affairs and a strong understanding of international regulations. Responsibilities include liaising with cross-functional teams, guiding regulatory processes, and maintaining compliance. This full-time position offers competitive compensation, generous benefits, and professional development opportunities in a diverse environment.

Benefits

25 days holiday

Pension scheme

Wellness Platform access

Discounted contact lens scheme

Qualifications

• Minimum 5 years’ experience in medical devices regulatory affairs/quality assurance preferred.
• Knowledge of international regulatory environments and product registration processes is preferred.
• Experience in the optical industry, specifically contact lenses, is a plus.

Responsibilities

• Support the creation, development, and implementation of global regulatory procedures.
• Provide regulatory guidance and education to project teams.
• Manage regulatory impact assessments for new product initiatives.
• File clinical investigation applications and manage queries with NPI RA colleagues.

Skills

Knowledge of applicable laws and regulations

Effective communication skills

Attention to detail

Ability to read and understand technical material

Analytical skills

Education

Bachelor's or graduate degree in a scientific or technical discipline

Tools

Computer skills

Job description

A renowned optical company in Eastleigh is seeking a Regulatory Affairs Specialist to manage regulatory strategies for new products. The ideal candidate will have over five years of experience in regulatory affairs and a strong understanding of international regulations. Responsibilities include liaising with cross-functional teams, guiding regulatory processes, and maintaining compliance. This full-time position offers competitive compensation, generous benefits, and professional development opportunities in a diverse environment.