Principal Regulatory Affairs Specialist – EMEA (Cluster Partner)

Job title: Principal Regulatory Affairs Specialist – EMEA

Department: Regulatory Affairs

Location: Southampton, UK / Gorinchem, Netherlands or Gothenburg, Sweden

GlS: P04

Working hours: UK – 37.5 hours per week, Netherlands or Sweden – 40 hours per week

Overview

The Principal Regulatory Affairs Specialist will provide expert level regulatory support and direction across our UK&I, BeNeLux and Nordic Clusters, for products from concept to launch, and beyond into post‑market, as well as regulatory processes. The Principal RA Specialist articulates and executes the agreed regulatory strategy for assigned corporate projects. Leads the creation, development and implementation of global/regional regulatory affairs procedures for marketed products and to maintain, update or remediate the company’s regulatory compliance status.

Essential Functions & Accountabilities

• Registration Activity
  • Reviews and approves regulatory documents for the registration of current and new products in assigned markets.
  • Oversees the maintenance of submission documents and agile databases in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information.
  • Maintains, updates and remediates regulatory files and documents as required, including communication across the EMEA RA team and other departments, sites or business units to provide regulatory status reports.
  • Coaches and mentors more junior team members with submissions.
  • Maintains up-to-date knowledge of regional and national regulations, guidelines and advisory documents required for marketing CooperVision products in a specified region.
  • Communicates applicable regulatory requirements to CooperVision Regulatory Affairs management and business partners.
  • Analyzes impact and communicates to management changes in regulations or requirements that have been identified.
  • Establishes and leverages working relationships with government, regulatory agencies and trade associations for the purpose of advocating CooperVision positions.
• Technical Documentation
  • Reviews compiled Technical Files for CE approval prior to submission.
  • Supports RA management with Notified Body requests for information.
  • Plays a significant role in technical audits in the UK, EU, ACE and MENA regions, including preparation, contingency planning, response, findings and close‑out activities.
• Support to CooperVision Processes
  • Represents the perspective of regulatory affairs within the company.
  • Interprets general business objectives and effectively presents information to manager and regions.
  • Reviews and approves product labeling.
  • Initiates IFUs and other required product labeling in line with relevant UK, EU, ACE & MENA requirements.
  • Supports “Own Brand” and “Private Label” customers and liaises with EU Competent Authorities and other ministries of health as necessary.
  • Provides input to Regulatory Affairs Impact Documents (RAIDS) from UK, EU, ACE & MENA perspectives.
  • Undertakes other administrative tasks to support CE marking and regional registrations.
  • Maintains professional behavior with internal and external business associates reflecting positively on CooperVision.
  • Acts as a resource on quality issues and proposes changes to minimise risks and enhance quality, reliability, safety and productivity.
  • Acts as spokesperson when appropriate regarding CooperVision practices, public policy, business interests; arranges for technical explanations from internal or external experts.
  • Supports RA compliance activities as necessary in assigned regions.
  • Independent management of multiple projects, departmental initiatives and day‑to‑day tasks.

About You

Experience

• 6–8 years of medical device regulatory experience.
• Technical writing experience.
• Experience evaluating manufacturing changes for impact on global regulatory affairs submissions.
• Medical device industry experience including strong working knowledge of MDD and MDR.
• Ability to operate in a business‑driven model, providing quick, salient analysis and concrete action plans with emphasis on understanding and anticipating business needs.
• Strong relationship‑building and influence skills; ability to interact credibly at senior levels.
• Experience with electronic document management systems; strong IT, problem‑solving, analytical and communication skills.
• Computer literate, intermediate skill in Word, Excel, Outlook, and familiarity with relational database systems (e.g., Agile Project Management).
• Flexible and able to self‑manage multiple priorities; effective in multinational/multicultural environments.
• Full, current driving license.

Knowledge, Skills and Abilities

• Understanding of ISO 13485 requirements and EU medical device regulations.
• Ability to read and understand technical material.
• Excellent attention to detail and organizational skills.
• Excellent written and verbal communication skills.
• Ability to work effectively alone or as part of a team; manage time effectively and complete tasks on time with general supervision.
• Experience reviewing and approving product labeling.
• Flexibility to work across UK sites.

What We Offer

• Competitive compensation and a comprehensive benefits package.
• Commitment to employees’ personal and professional development with extensive training to support career growth.
• Opportunity to help drive the company’s mission and make a positive impact in the vision care industry.

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