lavori da Editing in località United States

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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 Technical Writer / Clinical 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

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

• To provide Medical Device and IVD Clinical consultancy for LFH Regulatory and its associated clients.
• Fully support LFH Regulatory clients in ensuring required product portfolio are compliant with all regional regulations.
• Maintain LFH Regulatory clients Clinical Documentation to ensure compliance to all relevant requirements.
• Conduct Technical / Medical Writing.
• Ability to conduct literature reviews, assess clinical data, and collate findings into structured reports,
• Ability to critically evaluate scientific literature and clinical data,
• Skilled in identifying relevant clinical endpoints, performance claims, and safety data for regulatory submissions,
• Create, maintain and conduct gap assessments on documentation for clients, including but not limited to:

Clinical Evaluation,

Performance Evaluation,

Biological Evaluation,

Other clinical or performance documentation

Feedback clinical/performance inputs into Technical Files, Risk Management and documentation

Qualifications

• 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),
• 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.

To apply you must be based in the UK.

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