Regulatory Affairs Specialist – Field Based
Our client is a small, growing specialist Medical Device Consultancy. Due to continued growth, they have created a new vacancy for a Regulatory Affairs Specialist / Consultant.
This is an excellent opportunity for a RA Specialist to work on range of projects in a fully field / home based role.
Please apply today or contact Josh Craven at Indo Professionals for more detail. 01256 597 800 / firstname.lastname@example.org
Up to circa £55,000 per annum (depending on experience) plus benefits. Applicants seeking more or less will also be considered
Field based – can be based anywhere in UK
RA Specialist / Regulatory Affairs Consultant
Our client is looking for professionals with strong medical device regulatory experience, they can consider applicants seeking a step up into a senior level role or in a supporting role or someone who can work in a standalone role at a senior level. Further experience required;
- Experience of Software / Electronic / Programmable (60601, 62304) medical devices – highly advantageous
- Risk Management experience (14971) – ideally
- Post market surveillance / vigilance experience – ideally
- Degree level education – or relevant working experience
- Excellent communication, presentation skills
- Full UK driving license – must
Within this role the successful Regulatory Affairs Specialist / Consultant will be work within the technical, regulatory and quality teams of the client to provide consultancy services within regulatory areas of expertise, typical projects may involve;
- Set up of technical documentation & design dossiers – supporting CE marking and 510Ks
- Conduct or advise on design / product risk management activities
- Conduct or advise on post market surveillance and vigilance
- Support to maintain or expand market access to various markets including EU, USA
- Conduct or advise on validation projects
Indo Professionals is a specialist medical device staffing business focused on placing high calibre professionals into regulatory affairs, quality assurance and clinical research positions UK wide. If you are looking for a new career challenge or would like a career consultation with an industry expert, please contact the team today.