Senior Regulatory Affairs Lead — Medical Devices & NPD

QuidelOrtho Corporation; Pencoed; On-site; GBP 60,000 - 80,000; Full time

Job summary

A global diagnostics company in Pencoed, Wales, is seeking a Senior Regulatory Affairs Associate to oversee regulatory submissions, support new product development, and maintain compliance with health authorities. The ideal candidate possesses a Bachelor’s degree and at least 3 years of experience in medical device or pharmaceutical industries. This full-time role offers competitive benefits including a pension scheme and on-site gym facilities.

Benefits

Competitive base salary

Yearly salary reviews

Pension scheme

Bonus scheme

LinkedIn Learning

Life assurance

Healthcare scheme

Cycle-to-work scheme

25 days holiday + 8 bank holidays

Employee assistance programme

On-site gym facilities

Qualifications

• Minimum 3 years of experience in FDA and/or EU regulated medical device or pharmaceutical industry.
• Experience with 510(k) and/or BLA applications or EU Notified Body submissions.
• IVD industry experience preferred.

Responsibilities

• Support day-to-day regulatory affairs operations and new product development projects.
• Manage submissions of regulatory applications to health authorities.
• Represent RA function for lifecycle management and NPD project teams.

Skills

Interpersonal skills

Organizational skills

Communication skills

Ability to manage tasks/projects

Education

Bachelor’s degree in a scientific or related field

Equivalent regulatory/quality experience

Job description

A global diagnostics company in Pencoed, Wales, is seeking a Senior Regulatory Affairs Associate to oversee regulatory submissions, support new product development, and maintain compliance with health authorities. The ideal candidate possesses a Bachelor’s degree and at least 3 years of experience in medical device or pharmaceutical industries. This full-time role offers competitive benefits including a pension scheme and on-site gym facilities.