Principal Regulatory Affairs Specialist-NPI

Job Title: Principal Regulatory Affairs Specialist - NPI
Department: Regulatory Affairs
Location: Southampton, UK
Working Hours: Mon – Fri, 37.5 hours per week

CooperVision is one of the world’s leading manufacturers of soft contact lenses with a presence in over 100 countries. Being part of CooperVision means helping improve the way people see each day. It’s more than making contact lenses – it’s about giving lens wearers freedom and confidence to move about their daily lives. We’re all about bright futures – for our people and those who wear our contact lenses.

The Principal Regulatory Affairs (RA) Specialist – New Product Introduction (NPI) works independently to represent regulatory affairs on Life‑cycle Management (LCM), NPI and other project teams. The role liaises with internal functions on cross‑functional teams and interacts with senior leadership, clinical affairs, professional services, medical affairs, R&D, LCM, marketing, operations and external regulatory agencies.

As an expert in domestic and international medical device regulation and legislation, the Principal RA Specialist - NPI creates, develops, and implements global regulatory affairs procedures and educates others on global regulatory expectations and requirements. The specialist crafts regulatory strategies for assigned corporate projects, including new product development and manufacturing improvement initiatives.

• 
  
• Represents global RA and partners with project team members on development teams, providing regulatory guidance, education and assessment.
  
• Works independently to represent regulatory affairs on project teams, bringing new or modified products from concept through development to market using a risk‑based approach.
  
• Develops and executes pragmatic and innovative regulatory strategies to support timely introduction of new or revised products, in partnership with R&D and LCM.
  
• Serves as RA representative for Design Review Boards, reviewing and approving Design Control documentation to support projects through the Design and Development process.
  
• Develops documentation and information for global regulatory and/or clinical consultations and submissions, collaborating with regional RA, R&D and other functions as necessary (e.g., US FDA Q‑submissions, USAN applications, clinical investigation applications).
  
• Utilises project tools as appropriate to track and communicate submissions and project development to meet agreed schedules.
  
• Reports to partner functions, including regional RA teams, on project progress and associated regulatory activities.
  
• Creates technical documentation structures (including GSPR checklists) and summary documentation for new or revised products to support the Master Technical File (MTF) and Master Summary Technical Documentation (mSTED) processes.
  
• Provides technical documentation and information to regional RA partners in support of global product registration/approval activities.
  
• Liaises across regulatory affairs to ensure labelling requirements for new or revised products are understood and implemented.
  
• Participates in and contributes to global RA, R&D, and other business meetings as required.
  
• Completes Regulatory Affairs Impact Documents (RAIDs) as needed.
  
• Maintains regulatory files and documents per the requirements of the Quality Management System (QMS).
  
• Develops, implements, and maintains global regulatory procedures to ensure regulatory compliance.
  
• Keeps abreast of evolving global regulatory requirements.
  

Approximately 5% to global CooperVision locations.

• 
  
• In‑depth knowledge of applicable laws and regulations.
  
• Ability to read and understand highly technical material.
  
• Proficiency in reading and writing in English.
  
• Effective communicator, capable of conveying messages logically and concisely.
  
• Attention to detail with organisational skills.
  
• Independent self‑starter able to manage time effectively and complete tasks on time, while managing multiple priorities.
  
• Adapts readily to changes in workload, staffing, and scheduling.
  
• Compliance with company policies and procedures.
  
• Follows management direction and seeks assistance from supervisors when necessary.
  
• Conducts oneself professionally with colleagues, management, customers, and others, modelling corporate values.
  

• 
  
• Normal office environment.
  
• Sedentary with light physical effort necessary to perform the job.
  
• Extended periods of sitting and using a computer.
  

• 
  
• Knowledge of international regulatory environments, regulations and product registration processes is required.
  
• Strong computer, problem‑solving, analytical and communication skills.
  
• Minimum 10 years’ experience in medical devices regulatory affairs/quality assurance preferred.
  
• Experience representing RA on cross‑functional project teams preferred.
  
• Bachelor’s or graduate degree in a scientific or technical discipline preferred, with formal education in a regulatory discipline preferred.
  
• Experience working in the optical industry, specifically contact lenses, is a plus.
  

You’ll receive competitive compensation and a fantastic benefits package including bonus, 25 days holiday, pension scheme, access to our Wellness Platform to support mental health and wellbeing, a discounted contact lens scheme and much more. We are committed to our employees’ personal and professional development and offer extensive training to support your career growth and help every individual reach their full potential. We also provide access to LinkedIn Learning.

As a CooperVision employee, you’ll be welcomed into a diverse and progressive global business. We appreciate how important fostering an inclusive culture is and how different perspectives add value and contribute to our success.

All suitably qualified applicants will receive equal consideration and opportunities from CooperVision. If you like what you see, take the first step towards your Brighter Future and apply today! All other opportunities can be viewed at https://hcjy.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1.