Quality Assurance and Regulatory Affairs Consultant

Are you an experienced 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 Quality Assurance and Regulatory Affairs Consultant. We are open to full time as well as part time applicants between 3 to 5 days.

What benefits will you get?

Competitive Salary and compensation package: We understand the value of your skills and expertise. We offer:

• A salary of up to £60k pro rata depending on experience
• Company based bonus scheme
• Health benefits including life insurance and critical illness
• Flexible working

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. Not only this, as the business is rapidly growing year on year, there is no limitations on where you can go in the company with many exciting opportunities ahead !

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 clinical 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.

Our services include device development and CE/UKCA marking certification, global regulatory strategies, US FDA, quality management system creation and ongoing support to ISO 13485, internal/supplier audits, remediating audit findings, technical documentation, risk management activities to ISO 14971, clinical requirements, recalls and adverse event management, product registration, and UK Responsible Person services.

Responsibilities

Attend client meetings both remote and onsite as needed,

Implement full and partial quality management systems, that align with UK, EU, and US requirements/ISO 13485/21 CFR, by creating/writing procedures, controlled forms, and work instructions,

Maintain client quality management systems and provide QMS support to clients,

Conduct gap assessments and audit quality management systems,

Provide support to clients pre, during and post audit, including audit preparation, attending audits and assisting with non-conformities,

Create, maintain and conduct gap assessments on technical file documentation for clients, including but not limited to:

• Risk management,
• Post-market surveillance,
• Essential Requirements Checklist (ERCs) and General Safety and Performance Requirements (GSPRs),
• Clinical Evaluation,
• Biological Evaluation,
• Usability Engineering,
• Instructions for use and labels,
• Applied standards,

Register devices with regulatory authorities,

Review and prepare UK responsible person documentation,

Liaise with notified/approved bodies and competent authorities.

Attend and participate in team meetings both remote and face to face,

Create blog content for LinkedIn/Website and any other form of social media where required,

Create, update, and maintain internal LFH Regulatory business processes and document employee training records,

Attend exhibitions, conferences and network events.

No direct supervisory responsibilities.

Qualifications

• Degree educated or relevant industry experience.
• Scientific, Engineering or Medical background with regulatory experience within the medical devices/IVD sector (ideally 2 or more years’ experience),
• 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.
• Excellent attention to detail is essential.
• Suitable general IT skills.

To apply you must be based in the UK.

Remote working with occasional travel as and when needed to meet business need.