Hays
Clinical Evaluation / Medical Writing Consultant
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My client, a specialist medical device consultancy, is seeking an experienced Clinical Evaluation / Medical Writing Consultant to support the remediation of technical documentation for an established Class I paediatric medical device.
About the Role
This is a project-focused contract opportunity supporting a critical regulatory compliance programme. The successful consultant will work closely with an experienced regulatory specialist to help rebuild key areas of the technical documentation package and support ongoing UK MDR compliance activities.
Your new role
The project involves the remediation and reconstruction of technical documentation for a paediatric mobility device where historical design and technical records are limited. Significant work has already been undertaken internally. However, specialist expertise is now required to deliver several key work packages ahead of an important regulatory submission deadline.
- Opportunity to join immediately and make an immediate impact on project delivery.
- The client is seeking experienced consultants who can provide expert input on an ad hoc, deliverables-based basis.
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You will be responsible for supporting the development of clinical and risk management documentation, including:
- Authoring and maintaining the Clinical Evaluation Plan (CEP)
- Conducting and documenting comprehensive literature searches
- Producing literature review documentation and evidence logs
- Supporting preparation of the Clinical Evaluation Report (CER)
- Contributing to technical documentation required for UK MDR compliance
- Providing clinical input into the ISO 14971 Risk Management Process
- Supporting risk assessments from a clinical perspective
- Assisting with preparation and review of risk management documentation
- Working collaboratively with regulatory and quality specialists to ensure documentation is submission-ready
What you'll need to succeed
- Extensive experience in Clinical Evaluation for medical devices
- Proven track record authoring CEPs and CERs
- Experience conducting systematic literature reviews and literature appraisals
- Strong understanding of UK MDR and medical device regulatory requirements
- Experience contributing to technical files and technical documentation packages
- Knowledge of ISO 14971 Risk Management
- Ability to work independently and deliver high-quality documentation to tight timelines
- Experience with Class I medical devices
- Previous work on remediation or legacy documentation projects
- Experience supporting paediatric medical devices or products intended for children is ideal.
- Broader medical writing and regulatory documentation expertise
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What you need to do now
Before you apply for this position, it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.
If you are a Clinical Evaluation Specialist, Medical Writer, Regulatory Writer or Medical Device Documentation Consultant with strong CEP/CER experience and have immediate availability to support a high-priority remediation programme, we would be keen to hear from you. Click 'apply now' to forward an up-to-date copy of your CV, or call Roberta Atkins on 0203 465 0045 or email roberta.atkins@hays.com
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