Regulatory Affairs Specialist - NPI supports the creation, development, and implementation of global regulatory affairs procedures and educates others on global regulatory expectations and requirements. The role contributes to and implements regulatory strategies for corporate projects, including new product development and manufacturing improvement initiatives.
Requirements
- 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.
- 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.
Benefits
- Competitive compensation
- 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!
- Extensive training to support your career growth and help every individual to reach their full potential
- Access to LinkedIn Learning to help you develop in your career and grow with CooperVision
