Regulatory Affairs Specialist - NPI

Southampton, Hampshire, United Kingdom (On-site)

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Job title:
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 Regulatory Affairs (RA) Specialist – New Product Introduction (NPI) collaborates with RA colleagues to support the representation of regulatory affairs on Life‑cycle Management (LCM), NPI and other project teams. The RA Specialist – NPI liaises with internal functions on cross‑functional teams. The RA Specialist – NPI typically interacts with multiple functions of the business that include leadership, RA, clinical affairs, professional services, medical affairs, Research and Development (R&D), LCM, marketing, operations, and also with external regulatory agencies.

The RA Specialist – NPI supports the creation, development, and implementation of global regulatory affairs procedures and educates others on global regulatory expectations and requirements. The RA Specialist – NPI contributes to and implements regulatory strategies for corporate projects, including new product development and manufacturing improvement initiatives.

• Liaises with NPI RA colleagues to partner with project team members on development teams, providing regulatory guidance, education and assessment.
• Works independently to support the representation of regulatory affairs on project teams bringing new products (or modified products) from concept, through development, to market, using a risk‑based approach.
• Contributes to and executes pragmatic and innovative regulatory strategies to support the timely introduction of new or revised products, in partnership with R&D and LCM.
• Raises and manages regulatory impact assessments in support of new product development and manufacturing improvement initiatives.
• Supports the Design Review process, 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 NPI RA colleagues, 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.
• Files clinical investigation applications and supports the resolution of related queries etc. as necessary, liaising with NPI and regional RA colleagues.
• 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.
• Maintains regulatory files and documents per the requirements of the Quality Management System (QMS).
• Provides administrative support to the NPI RA team as may be necessary.
• Coordinates the provision of product and packaging samples for global registration…