Back to Job SearchAre you an experienced clinical medical device professional with a strong background in design controls, clinical evidence, and remediation programmes?
Our client is an established international consultancy supporting organisations across the Pharmaceutical and Medical Device sectors. With a strong global presence and a track record of delivering solutions in highly regulated environments, they are continuing to grow and are now seeking a Clinical SME, Design Controls Remediation to support ongoing and upcoming client projects in the USA.
This is a fully remote opportunity for a credible and technically strong clinical specialist who enjoys working on complex remediation activity and cross-functional evidence strategies.
The role
This position will play an important role in supporting design controls remediation work within the medical device space. You will work closely with wider technical teams to ensure clinical documentation and evidence packages are aligned with design control, validation, and regulatory expectations.
Key responsibilities
Responsibilities will include:
- Conducting gap analyses of clinical study plans, protocols, and data against design control and regulatory requirements
- Supporting the preparation of clinical evaluation reports, risk-benefit assessments, and post-market clinical follow-up plans
- Aligning clinical data with validation protocols and user needs documentation
- Providing sound clinical justification for design changes during remediation programmes
- Collaborating with pre-clinical specialists and systems engineers to support a robust and joined-up evidence strategy
About you
To be considered for this opportunity, you should be able to demonstrate:
- An advanced clinical degree together with medical device clinical research experience
- Clinical trial or clinical evaluation experience within ISO 14155 and FDA regulated environments
- Strong expertise in clinical risk management and evidence generation for regulatory submissions
- Previous experience supporting clinical gap remediation activity, ideally relating to DHF or pre-market approval projects
- Strong clinical study design, interpretation, and data analysis capability
- The ability to work effectively with cross-functional stakeholders in a remote environment
Why consider this role?
This is an excellent opportunity to join a well-regarded international consultancy working on important and technically complex projects within a highly regulated sector. You will have the chance to make a real impact, work alongside experienced professionals, and contribute to high-value remediation and compliance activity.
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.
