Sector: Life Sciences
Consultant: Life Sciences Team
Salary: £60000 - £70000
Job Status: Permanent / Full Time
I am currently searching for an experienced Regulatory Affairs Manager to based in Hertfordshire who is required to manage the team in the Regulatory Affairs department, including the RA Executives and Administrators.
Supporting the Regulatory Affairs Director, the Regulatory Affairs Manager will create and manage technical files for Class I, IIA and IIB medical devices and assist with the ISO 13485 & ISO 9001 Quality Management System.
This is a varied, hands-on role for a Regulatory Affairs Manager to oversee the regulatory requirements and develop regulatory strategies for this fast-growing multi-million £, global FMCG company, specializing in manufacturing and distributing unique, quality products within the healthcare industry.
Create and manage Technical Files for Class I, IIA and IIB Medical Devices (including but not limited to)
- Efficacy data
- Stability data
- Design history and design development
- Manufacturing instructions and procedures
- Risk Management
- Clinical evaluation
- ER checklist
Regulatory requirements for:
- Technical file data for BPR dossiers (Biocidal Product Regulations)
- Technical file data for Cosmetics Regulations, i.e. PIFs
- Technical file data for Detergent Regulations and additional EMC and LV data file
- Export registrations around the world
- 10+ Years Regulatory Affairs Experience (Medical Device)
- Degree educated in a scientific discipline
- QA Experience desirable
- Technical file writing experience
- Disinfectant experience desirable
- Able to understand relevant terminology
- In-depth knowledge of all application types
- Knowledge of EU regulatory requirements and guidelines
- Management level experience
- Experience of US Food & Drug Administration (FDA) and associated regulations (highly beneficial)?
This role is offering £70,000 and a brilliant bonus after 6 months pension and health cover. If you are interested in this please get in touch and send your CV, we are looking to interview candidates as soon as possible.