Role: Regulatory Affairs ( RA ) Consultant - Perm - Medical Devices
Location: Home Based
Salary: £40,000 - £45,000
Benefits: 25 days Holiday + 8 Bank Holidays + Pension
Flexible working hours!
Russell Taylor Group has a fantastic, rare opportunity to join a small Medical Device Company working from home. The role is due to the continued growth of our clients business and they are now looking to add to the business a Medical Devices Regulatory Affairs Consultant. You will have experience within ISO 13485, MDD 93/42/EEC and MDR 2017/745 - If you do not you will not be successful.
- This is quite a unique varied role, and you will be working directly with some of the worlds leading Medical Device Companies across the UK and potentially abroad.
- Dealing with technical documentation relating to MDD 93/42/EEC and MDR 2017/745.
- Working on numerous QMS systems.
- Working independently on client projects.
- Build strong working relationships with clients.
- Complete all tasks set and on time for the client.
- You will be working closely with some of the leading medical device experts the industry has to offer!
- A degree in the field of science, medicine or engineering
- Experience within the Medical Device industry within a regulatory role.
- Experience of working with technical documentation under MDD 93/42/EEC / MDR 2017/745
- Knowledge of compliance with International standards e.g. ISO 13485.
- Demonstrate excellent communication and organisational skills.
- Experience within the IVD industry within a regulatory role.
- Experience of working with technical documentation under IVDD 98/79/EC / IVDR 2017/746.
- Communication/audit experience with notified bodies and/or competent authorities.
- US FDA and MDSAP experience.
- International regulatory submissions.
Keywords; RA, Regulatory, 13485, Medical Device, IVD, MDR