Job Description
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.
ROLE:
- 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!
PERSON:
Must haves:
- 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.
Desirable:
- 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
Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our Privacy Policy h t t p s : / / w w w . r u s s e l l - t a y l o r . c o . u k / p r i v a c y - p o l i c y on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or the GDPR please contact us on h r @ r u s s e l l - t a y l o r . c o . u k
