Life Science People are exclusively representing a highly reputable Regulatory Affairs Consultancy who is looking for a UK Responsible Person as a result of the legislation change.
The UK Responsible Person is a newly created role and you will be the appointed Regulatory Affairs representative for the company and provide oversight and advice for the reviewing and assessing CE/UKCA Technical Files to ensure compliance to current EU or UK Medical Device Regulations with the company's customers.
Reporting to the Managing Director, your role will include:
- To review and assess CE/UKCA Technical Files to ensure compliance with current EU or UK Medical Device Regulations.
- Provide accurate guidance/advice to clients to bring files into compliance with current EU or UK Medical Device Regulations.
- To provide regulatory support to other members of the team and Managing Director when requested.
- Oversea regular communication with clients to provide accurate and concise updates on regulatory changes that could affect their businesses.
- To represent the Company professionally and courteously.
- Any other task as required by the Company directors.
Skills and Experience Required:
- Degree or equivalent certification in a life science discipline.
- To be experienced and knowledgeable of the medical device industry for medical device practical usages, their application and design, and manufacturing and regulatory affairs.
- A minimum of five years' experience is desired.
- Can assess all necessary and specific medical device regulatory obligations and be able to advise staff and clients accordingly.
- To be experienced enough to verify the technical, design, and manufacturing information.
- QMS ISO 13485 experience.
- Risk Management ISO 14971 experience.
- Knowledge of electrical and software safety standards.
- Auditing experience.
- Report writing skills.
- Experience in design and manufacturing processes.
If interested, please submit your CV and cover letter highlighting your expertise to the role. You will be sent a confirmation of acknowledgement, please note feedback can take up to 2 weeks. If you have been selected for an interview the process will be divided into the following stages:
First stage - Initial screening call with HR/TA Manager
This is a general call to find out a little bit about what you would be looking for within the organisation and to provide some general details about yourself.
Final stage - Virtual Call with HR and the Managing Director
This will be a virtual call and you will have an opportunity to understand further information on the requirements for the positions and assess your competencies and cultural fit with the profile briefing.
This is a full-time permanent position, paying a competitive salary. You will be based in the company's UK site in Warwickshire, applications of candidates who are not local to the site will also be considered. Full details will be provided upon application. If interested, please send me an email with a convenient time to give you a call.