Regulatory Affairs & Clinical Consultant
Are you an experienced regulatory affairs and/or clinical professional looking for a new challenge? If so, we have just the opportunity for you! LFH is a top medical device consultancy company that is seeking a permanent Regulatory Affairs & Clinical Consultant. We are open to
full time
as well as
part time
applicants between 3 to 5 days. What benefits will you get? A salary of up to
£55k pro rata
depending on experience Company based bonus scheme Professional growth and development:
You’ll have the opportunity to work on a diverse range of projects, from writing and editing regulatory documents to providing oversight for outsourced deliverables to our clients. You will be able to enhance your skills and broaden your knowledge in the field of medical device regulation. Stimulating work environment:
Join a team at the forefront of medical device & IVD regulation, where every day brings new challenges and opportunities to make a difference and learn new things. Collaborate with cross-functional teams and contribute to the development of crucial regulatory documents that impact the advancement of medical technology. About LFH Regulatory We work with varying companies that have diverse ranges of technologies which offers a stimulating work environment, and ample opportunities for professional growth and development. If you like working from home, know that this job is fully remote but with occasional travel. The Role Description Client facing responsibilities include: Onboarding new clients and exploring new business opportunities during client meetings Attending client meetings both remote and onsite as needed Creating regulatory strategies for global markets including classification of medical devices and IVDs Creating, maintaining, and conducting gap assessments on technical file documentation for clients, including: Essential Requirements Checklist (ERCs) General Safety and Performance Requirements (GSPRs) Clinical Evaluation Biological Evaluation Usability Engineering Instructions for use and labels Applied standards Registering devices with regulatory authorities Reviewing and preparing UK responsible person documentation Liaising with Notified/Approved Bodies and Competent Authorities Providing support to clients pre, during and post audit, including audit preparation, attending audits, and assisting with non-conformities What are the requirements? Degree educated or relevant industry experience Scientific, Engineering or Medical background with clinical and regulatory experience within the medical devices/IVD sector (ideally 2 or more years’ experience) Substantial experience in the compilation and review of Performance Evaluation/ Clinical Evaluation documentation and EU/UK technical documentation for CE/UKCA marking US experience is desirable Assess all necessary and specific medical device regulatory obligations and to be able to advise staff and clients accordingly An understanding of ISO 13485 and/or FDA 21 CFR Part 820 Must work well within a team with good interpersonal and communication skills Commercial awareness and appreciation Excellent attention to detail is essential Seniority level
Mid-Senior level Employment type
Other Job function
Research, Analyst, and Information Technology Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr
Are you an experienced regulatory affairs and/or clinical professional looking for a new challenge? If so, we have just the opportunity for you! LFH is a top medical device consultancy company that is seeking a permanent Regulatory Affairs & Clinical Consultant. We are open to
full time
as well as
part time
applicants between 3 to 5 days. What benefits will you get? A salary of up to
£55k pro rata
depending on experience Company based bonus scheme Professional growth and development:
You’ll have the opportunity to work on a diverse range of projects, from writing and editing regulatory documents to providing oversight for outsourced deliverables to our clients. You will be able to enhance your skills and broaden your knowledge in the field of medical device regulation. Stimulating work environment:
Join a team at the forefront of medical device & IVD regulation, where every day brings new challenges and opportunities to make a difference and learn new things. Collaborate with cross-functional teams and contribute to the development of crucial regulatory documents that impact the advancement of medical technology. About LFH Regulatory We work with varying companies that have diverse ranges of technologies which offers a stimulating work environment, and ample opportunities for professional growth and development. If you like working from home, know that this job is fully remote but with occasional travel. The Role Description Client facing responsibilities include: Onboarding new clients and exploring new business opportunities during client meetings Attending client meetings both remote and onsite as needed Creating regulatory strategies for global markets including classification of medical devices and IVDs Creating, maintaining, and conducting gap assessments on technical file documentation for clients, including: Essential Requirements Checklist (ERCs) General Safety and Performance Requirements (GSPRs) Clinical Evaluation Biological Evaluation Usability Engineering Instructions for use and labels Applied standards Registering devices with regulatory authorities Reviewing and preparing UK responsible person documentation Liaising with Notified/Approved Bodies and Competent Authorities Providing support to clients pre, during and post audit, including audit preparation, attending audits, and assisting with non-conformities What are the requirements? Degree educated or relevant industry experience Scientific, Engineering or Medical background with clinical and regulatory experience within the medical devices/IVD sector (ideally 2 or more years’ experience) Substantial experience in the compilation and review of Performance Evaluation/ Clinical Evaluation documentation and EU/UK technical documentation for CE/UKCA marking US experience is desirable Assess all necessary and specific medical device regulatory obligations and to be able to advise staff and clients accordingly An understanding of ISO 13485 and/or FDA 21 CFR Part 820 Must work well within a team with good interpersonal and communication skills Commercial awareness and appreciation Excellent attention to detail is essential Seniority level
Mid-Senior level Employment type
Other Job function
Research, Analyst, and Information Technology Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr
