Southampton, Hampshire, United Kingdom (On-site)
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Job Description
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
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.
Scope
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.
Job Summary
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.
Essential Functions & Accountabilities
- 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 activities as required.
- Develops, implements, and maintains global regulatory procedures to ensure regulatory compliance.
- Keeps abreast of evolving global regulatory requirements.
Travel Requirements
Approximately 5% to global CooperVision locations.
Knowledge, Skills and Abilities
- Knowledge of applicable laws and regulations.
- Ability to read and understand highly technical material.
- Proficiency in reading and writing in English.
- Effective communicator, being able to convey messages in a logical and concise manner.
- Has attention to detail with organizational skills.
- Is an independent self‑starter able to manage time effectively and complete tasks on‑time. Is flexible and able to self‑manage multiple priorities.
- Works scheduled hours and ready to work at scheduled start times. Adapts readily to changes in workload, staffing, and scheduling.
- Complies with company policies and procedures.
- Complies with management direction. Seeks assistance from supervisor in identifying and reporting problems or concerns relating to job functions.
- Conducts self in a professional manner with colleagues, management, customers, and others. Models the corporate values.
- Normal office environment.
- Sedentary to light physical effort necessary to perform the job.
- There will be extended periods of sitting and using a computer.
Experience and Education
- Knowledge of international regulatory environments, regulations and product registration processes is preferred.
- Strong computer skills, problem solving ability, analytical and communication skills.
- Minimum 5 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. Formal education in a regulatory discipline preferred.
- Experience working in the optical industry, specifically contact lenses, is a plus.
What we offer
You’ll receive competitive compensation and a fantastic benefits package including 25 days holiday, pension scheme, access to our Wellness Platform to support you in 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 to reach their full potential. To help us achieve our goals, we’ll give you everything you need to help you achieve yours. We also provide access to LinkedIn Learning to help you develop in your career and grow with CooperVision.
What you can expect
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. If you like what you see, take the first step towards your Brighter Future and apply today! All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.
Please view our careers page at https://hcjy.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1 to view all other opportunities.
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Locations 36 School Lane, Eastleigh, Hampshire, SO53 4LY, GB (On-site)
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