Back to Job SearchROLE OVERVIEW
We are currently looking for a Clinical SME – Design Controls Remediation to join a leading provider in the Pharmaceutical and Medical Device industries. This is a remote opportunity for a skilled professional eager to contribute to innovative projects in a global organization that has been at the forefront of the sector since 1998.
An exciting opportunity for a Clinical Subject Matter Expert to support ongoing and upcoming client projects, focusing on design controls, clinical evaluation, and regulatory compliance within the medical device domain. You will play a vital role in ensuring clinical data integrity and supporting remediation efforts across various stages of product development.
KEY DUTIES AND RESPONSIBILITIES
Your duties as the Clinical SME – Design Controls Remediation will be varied however the key duties and responsibilities are as follows:
• Conducting gap analyses of clinical study plans, protocols, and data against design control and regulatory expectations.
• Supporting clinical evaluation reports, risk-benefit analysis, and post-market clinical follow-up planning.
• Aligning clinical data with validation protocols and user needs documentation.
• Providing clinical justification for design changes during remediation projects.
• Collaborating with Pre-Clinical SMEs and Systems Engineers to develop comprehensive evidence strategies.
• As the Clinical SME – Design Controls Remediation, you will ensure clinical evidence supports regulatory submissions and complies with ISO 14155 and FDA regulations.
ROLE REQUIREMENTS
To be successful in your application to this exciting role as the Clinical SME – Design Controls Remediation we are looking to identify the following on your profile and past history:
• A Degree or higher level in a relevant field (e.g., Medical, Clinical Research, Biomedical Engineering).
• Proven experience in clinical trial or clinical evaluation within the medical device or pharmaceutical sectors, with knowledge of ISO 14155 and FDA regulations.
• Extensive expertise in clinical risk management, evidence generation, and clinical gap remediation for DHF or pre-market approval projects.
WHAT’S IN IT FOR YOU?
Join our client’s innovative global team and work on impactful projects in a fast-growing industry. Benefit from flexible remote working arrangements, opportunities for professional growth, and the chance to be part of a company dedicated to advancing medical solutions that improve lives worldwide.
Key Words: clinical / medical device / regulatory compliance / remediation / clinical data analysis / ISO 14155 / FDA regulations / risk management / product development / remote working
"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".
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.
