Job Title: Regulatory Affairs Specialist
Location: West Sussex
Industry: Medical Devices
Salary: £40,000- £45,000 plus pension & benefits
This is a fantastic and very unique opportunity within a global leading organistaion, enjoying an autonomus approach to your work and a structure in which you will enjoy excellent progression opportunities and scope to develop your role.
This is a particualry exciting time to join as our client embark on a new phase of developments for their products after a lot of investment and research.
This a very unique platform to progress quickly within a global leading company.
Our client is an internation leader in science, present in over 50 countries. The mission simply is to empower their customers to make the world healthier and cleanier through accelerated research, tackling analytical health challenges and improved patient diagnostics.
This is an autonomous role ensuring that the site fulfils the regulatory requirements necessary to place products on the market and ensure ongoing compliance to applicable regulations.
This is a key position reporting into the RA Manager (Europe).
- Be the primary Regulatory Affairs representative for a marquee product range as well as the Regulatory Affairs representative for the site and its activities.
- Develop and execute global regulatory strategies and manage the pre-market submission of the products as well as support the registration of distributed products as necessary.
- Be responsible for the planning and implementation of new and updated regulations as applicable to products while working in coordination with global regulatory affairs
- Act as the lead on Regulatory Affairs within a cross-functional project team, providing influence for New Product Development, changes to existing products and other functions for the complete life-cycle management of products.
- Manage internal relationships; liaising with Quality Assurance, Research & Development, Production Engineering, Operations and Manufacturing, IT, Clinical Research and subsidiaries and distributors
- Execute and maintain procedures to ensure compliance with all applicable regulatory requirements for the vigilance system including product complaints reporting.
- Manage the Complaint System and Product Experience Reports.
- Manage relationships with regulatory bodies, notified bodies and trade associations.
- Ensure compliance for vigilance reporting and link back into the risk management process ( ISO 14971).
- Create and maintain technical files for Non Class III devices.
- Supervise the Vigilance Support Administrator.
- KPI areas: Compliance with vigilance requirements; Non Class III technical file compliance.
Experience and Skills Required for the Vigilance and Regulatory Affairs Specialist
- Detailed knowledge of the regulations and guidance for international markets including, EU, FDA, Australia, Japan, Canada and other distributed markets.
- Particular knowledge and experience in 510K submissions.
- Complex Technical File compilation.
- Navigation of complex pre-market submissions.
- Experienced and knowledgeable in Quality Management Systems - 21 CFR 820 QSR, ISO 13485 Medical devices.
- Detailed knowledge of Complaints Management and regulatory requirements for reporting of adverse events and product events.
- Graduate level or equivalent in a life science subject.
- Previous supervisory experience or project lead experience.
Sound like you? Apply NOW! Don't miss out on this exciting opportunity as a Regulatory Affairs Specialist.
If you have any further queries regarding this role please call James Powell on: 0203 8000509
Projectus Consulting are a leading Medical Device Recruitment Consultancy. We're a niche business who provide a highly specialist service to both employers and candidates in the Medical Technology Sector.
We are dedicated to finding the right opportunity for you.