Pre-Clinical Medical Device Subject Matter Expert

Are you an experienced pre-clinical medical device professional with strong expertise in design controls, testing strategies, and remediation activity?

Our client is an established international consultancy supporting organisations across the Pharmaceutical and Medical Device sectors. With a strong global footprint and a track record of delivering solutions in highly regulated environments, they are continuing to grow and are now seeking a Pre-Clinical SME, Design Controls Remediation to support ongoing and upcoming client projects in the USA.

This is a fully remote opportunity for a technically strong specialist who can bring sound scientific judgement, regulatory awareness, and a practical approach to complex remediation programmes.

The role

This position will play an important role in supporting design controls remediation work within the medical device sector. You will be responsible for helping to ensure that pre-clinical evidence, testing documentation, and associated justifications are aligned with regulatory, design control, and risk management expectations.

You will also work closely with wider technical teams to support a robust and integrated evidence strategy.

Key responsibilities

Responsibilities will include:

• Evaluating gaps in pre-clinical testing plans, protocols, and reports against design control requirements
• Supporting the development and updating of biocompatibility, performance, and animal study documentation
• Integrating pre-clinical results into risk management files and verification and validation strategies
• Providing technical justification for pre-clinical evidence within regulatory submissions
• Collaborating with clinical subject matter experts and systems engineers to ensure a joined-up and comprehensive evidence approach

About you

To be considered for this opportunity, you should be able to demonstrate:

• A degree in Biomedical Engineering or a related scientific or engineering discipline
• Pre-clinical testing experience within the medical device sector, including work under ISO 10993 and GLP standards
• Expertise in bench testing, animal models, and biocompatibility risk management
• Experience supporting pre-clinical gap assessments and design history file remediation activity
• Strong regulatory writing, analytical, and data interpretation skills
• The ability to work effectively across multidisciplinary teams in a remote setting

Why consider this role?

This is an excellent opportunity to join a well-regarded international consultancy working on technically complex and high-value projects in a highly regulated environment. You will have the chance to contribute to meaningful remediation and compliance activity while collaborating with experienced professionals across a broader global network.

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.