Senior Regulatory Affairs Associate

QuidelOrtho Corporation; United Kingdom; 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

Senior Regulatory Affairs Associate – QuidelOrtho

Overview

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world‑leading in‑vitro diagnostics company with award‑winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. With over 6,000 employees and operations in more than 130 countries, we deliver fast, accurate and consistent testing where it matters most – from hospital labs to point‑of‑care. Our culture prioritises employee happiness, inspiration and engagement, and we are committed to transforming diagnostics into a healthier future for all.

Position

Senior Regulatory Affairs Associate (Professional 3) – permanent, based in Pencoed, Wales, United Kingdom.

Responsibilities

• Support day‑to‑day regulatory affairs operations and new product development (NPD) projects within the Regulatory Affairs department in the Clinical Laboratories business units.
• Manage and oversee the coordination, compilation and submission of regulatory applications to health authorities with minimal oversight.
• Provide regulatory support across Clinical Laboratory product lines.
• Represent RA function for lifecycle management and NPD project teams for reagents (e.g., assays, calibrators, controls).
• Support base business activities such as Notified Body submissions, labelling and change‑management reviews (change requests, change notices).
• Generate and manage Regulatory Plans/Strategies and prepare FDA Class II/III submissions; support the International Regulatory Affairs team.
• Coordinate, compile and submit regulatory applications to international regulatory agencies; interact with agencies and Regional QRC personnel to expedite pending applications, resolve regulatory matters and manage development meetings.
• Maintain compliant regulatory status for currently marketed products: technical files, design history files, labelling and promotional materials, and regulatory assessment of changes.
• Interpret regulatory requirements, determine strategy to obtain registrations, and provide guidance to business partners on regulatory risks and timelines.
• Support any manufacturing site relocations.

Qualifications

• Bachelor’s degree in a scientific or related field, or equivalent regulatory/quality experience.
• Minimum 3 years of experience in an FDA and/or EU (IVDR) regulated medical device or pharmaceutical industry; IVD industry experience preferred.
• Excellent interpersonal, teamwork and written communication skills.
• Strong organizational skills and ability to manage multiple tasks/projects.
• Capacity to work with business partners across geographies and time zones.
• Experience supporting regulatory strategies and product development programmes.
• Direct experience with 510(k) and/or BLA applications or EU Notified Body submissions for IVD products or biological drug products.
• Desired experience with combination product regulations.

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 (milestone increases available)
• Employee assistance programme
• On‑site gym facilities

Additional Information

Seniority Level: Mid‑Senior level

Employment Type: Full‑time

Job Function: Legal

Industries: Medical Equipment Manufacturing

Location: Pencoed, Wales, United Kingdom