Regional Regulatory Affairs Manager

QuidelOrtho

United Kingdom

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).

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.