Back to Job SearchROLE OVERVIEW
We are currently looking for a Pre-Clinical Subject Matter Expert – Design Controls Remediation to join a leading global organisation operating within the Pharmaceutical and Medical Device industries. This is a remote role based in the US, offering an exciting opportunity for a skilled professional to contribute to innovative projects within a rapidly expanding company.
An exciting opportunity for a Pre-Clinical SME to support ongoing and upcoming project activity, ensuring compliance and integration of pre-clinical testing strategies within a dynamic, forward-thinking environment. This role is ideal for someone with a strong background in biomedical engineering and medical device testing, eager to apply their expertise in a global leader.
KEY DUTIES AND RESPONSIBILITIES
Your duties as the Pre-Clinical SME will be varied however the key duties and responsibilities are as follows:
- Evaluating gaps in pre-clinical testing plans, protocols, and reports against design control requirements to ensure regulatory compliance.
- Supporting the development or updating of biocompatibility, performance, and animal study documentation in line with industry standards.
- Integrating pre-clinical results into risk management files and verification/validation strategies for seamless regulatory submission.
- Providing technical justification for pre-clinical evidence across various regulatory documentation.
- As the Pre-Clinical SME, you will collaborate closely with Clinical SMEs and Systems Engineers to align evidence and ensure coherent project delivery.
ROLE REQUIREMENTS
To be successful in your application to this exciting role as the Pre-Clinical SME, we are looking to identify the following on your profile and past history:
- A Degree or higher level in Biomedical Engineering or a related field.
- Proven experience with pre-clinical testing in medical devices, specifically under ISO 10993 and GLP guidelines.
- Expertise in bench testing, animal models, and biocompatibility risk management.
- Strong regulatory writing skills and the ability to interpret complex data to support compliance and submissions.
WHAT’S IN IT FOR YOU?
Joining our client means becoming part of a pioneering organisation shaping the future of medical device development. You will work within a global team focused on innovation and quality, with opportunities to influence regulatory strategies and drive impactful projects. This role offers flexibility, ongoing professional development, and the chance to be at the forefront of industry advancements.
Key Words: Pre-clinical / SME / Design Controls / Remediation / Medical Devices / ISO 10993 / GLP / Biocompatibility / Regulatory Submission / Risk Management / Validation / Collaboration / Remote
“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.
