Technical Writer

JR United Kingdom; Wolverhampton; Remote; GBP 40,000 - 60,000; Full time

Job summary

A leading medical device consultancy is seeking a Technical Writer / Clinical Consultant to provide regulatory consultancy and support clients in compliance with medical device regulations. This role offers full-time and part-time options, competitive salary, and the chance to work on diverse projects with growth opportunities.

Benefits

Company-based bonus scheme

Health benefits including life insurance and critical illness coverage

Qualifications

• Relevant degree or experience in science, engineering, or medicine.
• Clinical and regulatory experience in medical devices/IVD (ideally 2+ years).
• Familiarity with CE/UKCA marking documentation.

Responsibilities

• Provide consultancy for Medical Device and IVD products.
• Support clients to meet product compliance with regulations.
• Conduct technical/medical writing and maintain clinical documentation.

Skills

Teamwork

Interpersonal skills

Communication skills

Attention to detail

Education

Degree or relevant industry experience

Job description

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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 seeking a permanent Technical Writer / Clinical Consultant. We are open to full-time as well as part-time applicants, working between 3 to 5 days a week.

What benefits will you get?

Competitive Salary and Compensation Package: We value your skills and expertise, offering:

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

Professional Growth and Development: You’ll work on diverse projects, from writing and editing regulatory documents to overseeing outsourced deliverables. This role allows you to enhance your skills and expand your knowledge in medical device regulation. As the company is growing rapidly, there are many exciting opportunities for advancement!

Stimulating Work Environment: Join a team at the forefront of medical device & IVD regulation, where each day offers new challenges and learning opportunities. Collaborate with cross-functional teams and contribute to developing critical clinical documents that impact medical technology advancements.

About LFH Regulatory: We work with various companies across different technologies, providing a stimulating environment and ample professional growth opportunities. This role is fully remote with occasional travel.

Our services include device development, CE/UKCA marking certification, global regulatory strategies, US FDA compliance, quality management system support (ISO 13485), audits, remediations, technical documentation, risk management (ISO 14971), clinical requirements, recalls, adverse event management, product registration, and UK Responsible Person services.

Responsibilities:

• Provide Medical Device and IVD Clinical consultancy for LFH Regulatory and clients.
• Support clients in ensuring their product portfolios comply with regional regulations.
• Maintain clinical documentation to meet relevant requirements.
• Conduct technical/medical writing.
• Review literature, assess clinical data, and compile findings into reports.
• Critically evaluate scientific literature and clinical data.
• Identify relevant clinical endpoints, performance claims, and safety data for regulatory submissions.
• Create, maintain, and conduct gap assessments on documentation, including Clinical Evaluation, Performance Evaluation, Biological Evaluation, and other clinical or performance documentation.
• Provide feedback on clinical/performance data for Technical Files, Risk Management, and other documentation.

Qualifications:

• Degree or relevant industry experience.
• Background in science, engineering, or medicine with clinical and regulatory experience in medical devices/IVD (ideally 2+ years).
• Experience in compiling and reviewing Performance and Clinical Evaluation documentation for CE/UKCA marking.
• US regulatory experience is desirable.
• Understanding of ISO 13485 and/or FDA 21 CFR Part 820.
• Excellent teamwork, interpersonal, and communication skills.
• High attention to detail.

Applicants must be based in the UK. Remote working with occasional travel is required.