Regional Regulatory Affairs Manager

The Opportunity 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. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

Your new role: As the Regional Regulatory Affairs Manager you will provide regulatory affairs leadership and expertise to support product registrations and lifecycle management across the United Kingdom, Europe, and Canada. You will be responsible for ensuring regulatory requirements are met in accordance with country-specific IVD regulations, as applicable. The role serves as QuidelOrtho-appointed UK Responsible Person (UKRP) and manages the UKCA-mark and QO’s relationship with the UK Approved Body (UKAB). The role closely works with distributors, service partners, and internal global regulatory teams to obtain and maintain product registrations and support commercial expansion.

What you’ll be doing:

• Lead the team that serves as the primary regulatory lead(s) for the UK, Europe, and Canada markets, coordinating registration strategies with Business Unit Regulatory Affairs and regional leadership.
• Manage efforts or work directly with distributors and authorized representatives to prepare, submit, and maintain product registrations and approvals.
• Lead and support regulatory cost reduction initiatives, including optimization of submission strategies, consultant usage, and distributor processes.
• Provide regulatory guidance to global and regional commercial teams to support new product introductions, market expansions, and lifecycle management.
• Determine regulatory pathways, risk classifications, and submission requirements for each country along with copy-review approval of promotional material.
• Manage interactions with local regulatory authorities through distributors or consultants, ensuring timely responses to questions, deficiencies, and renewals.
• Monitor regulatory changes and emerging requirements in assigned markets, communicating risks and opportunities to Business Unit Regulatory Affairs.
• Support regional tender/RFP processes.
• Participation in process improvement initiatives.
• Represent Regulatory for external and internal audits.

What you’ll need to succeed:

• Education: Bachelor’s degree in a scientific discipline (e.g. Pharmacy, Chemistry, Biology, Engineering or related). Advanced degree an asset (MSc, PhD).
• Experience: Regulated industry (Medical Device, IVD, or Drugs). Previous experience of leadership managing regulatory staff.
• Technical Skills: Strong knowledge of UK, European, and Canadian IVD regulatory requirements. Ability to develop and adhere to annual operational budgets.
• Soft Skills: Strong project management, problem solving, communication, and negotiation skills. Demonstrated ability to lead a high-performing regulatory affairs team.
• Travel: Up to 10%; domestic and international travel.
• Language: Fluent in English (advanced written and verbal comprehension).
• Familiarity with electronic document management systems and Microsoft Office Suite products (Excel, SharePoint, etc).
• Strong organizational and presentation skills.

Preferred Skills:

• Certificate in Quality Management or Regulatory Affairs
• Fluency in French or other European languages an asset
• Experience working with distributors and third-party regulatory consultants

What we offer:

• Competitive Salary
• Yearly Salary Reviews
• Attractive Pension Scheme
• Bonus Scheme
• Life Assurance
• Private Medical (If applicable)
• LinkedIn Learning
• Cycle to Work Scheme
• Free Onsite Gym
• Subsidised Canteen
• 25 days Holidays + 1 QuidelOrtho Day + 8 Bank Holidays (Milestone Increases Available)
• Employee Assistance Programme
• Reward & Recognition Programmes
• State-Of-The-Art facilities
• Exceptional career developmental prospects
• Strong culture centred around collaboration & customer focus.

Equal Opportunity QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at recruiting@quidelortho.com