We are partnering with a very dynamic and fast growing company who specialise in specialise in manufacturing and distributing an innovative portfolio of products within the healthcare industry and are the number one provider in several of their specialist product lines. This company distribute within over 45 countries worldwide and with new emerging markets on the horizon have the potential to reach 60 worldwide countries.
They continue to enjoy incredible growth and profits and this is an incredible time to join as Regulatory Affairs Executive for their Medical Devices division.
Our client has a strong team ethic and culture and will provide bespoke training and development options for staff.
This is role is based in North London.
Job Description for the Regulatory Affairs Executive
This position is an RAQA spilt of 80:20.
This position is focused on the creation and management of Technical Files for Class I, IIA and IIB Medical Devices:
- Efficacy data and Stability data
- Design history and design development
- Manufacturing instructions and procedures
- Risk Management
- Clinical evaluation
- ER checklist
This role will focus both on renewals for existing products as well as registrations for up to 6 new products going to market.
In addition to the core focus on medical devices you will enjoy the variety of also supporting colleagues
- Technical file data for Biocidal Procut Regulations
- Technical file data for Cosmetics Regulations, i.e. PIFs
The Regulatory Affairs Executive will also spend approximately 20% of their time supporting the management of ISO 13485 & ISO 9001 Quality Management System (including but not limited to).
Experience and Qualifications required for the Regulatory Affairs Executive
- BSc (or equivalent) in Science
- Experience of the MDD 93/42/EEC with experience of Technical file building and submissions under this Directive
- Established experience in Regulatory Affairs within the Medical Device industry.
- QA experience in running an ISO 13485 quality system is desirable
- Experience in Cosmetic regulatory affairs and / or the Biocides Directive is desirable
- Experience within the pharma industry- GDP/GMP, good documentation
- A strong communicator with good negotiation and relationship-building skills
- A good team player for this collaborative and dynamic department.
There will be an element of travel throughout the E.U.
Sound like you? Apply NOW! Don't miss out on this exciting opportunity as a Regulatory Affairs Executive
If you have any further queries regarding this role please call James Powell 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.