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

A brighter future awaits you
Cooper Vision is one of the world’s leading manufacturers of soft contact lenses with a presence in over 100 countries. Being part of Cooper Vision 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 Principal RA Specialist - NPI liaises with internal functions on cross-functional teams. The Principal RA Specialist - NPI typically interacts with multiple functions of the business that includes senior leadership, RA, clinical affairs, professional services, medical affairs, Research and Development (&D), LCM, marketing, operations, and also with 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 Principal RA Specialist - NPI creates, develops and implements 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 products (or modified products) from concept, through development, to market, using a risk-based approach.
• Develops and executes pragmatic and innovative regulatory strategies to support the timely introduction of new or revised products, in partnership with R&D and LCM.
• Serves as RA representative for Design Review Boards, including the review and/or approval of 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. Examples may include US FDA Q-submissions, American Medical Association United States Adopted Name (USAN) applications, clinical investigation applications etc.
• Utilises project tools as appropriate to track and communicate submissions and project development to meet agreed upon schedules.
• Reports to partner functions, including regional RA teams, on the progress of projects and associated regulatory activities.
• Creates technical documentation structures (including General Safety and Performance Requirements (GSPR) checklists) and summary documentation for new and/or revised products in support of 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 that labelling requirements for new and/or revised products are understood and implemented.
• Participates in and inputs to global RA, R&D, and other business meetings as required by the organisation.
• Completes Regulatory Affairs Impact Document (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 Cooper Vision locations.

• In-depth knowledge of applicable laws and regulations.
• Ability to read and understand highly technical material.
• Proficiency in reading…