Back to Job SearchROLE OVERVIEW
We are currently looking for a Clinical Scientist – Design Controls Remediation to join a leading global provider in the Pharmaceutical and Medical Device industries, supporting ongoing and upcoming projects in the US. This is an exciting opportunity for a dedicated professional to contribute to critical aspects of clinical evidence management, ensuring compliance and supporting innovative medical device development from the comfort of your home.
As part of our client's dynamic team, you will play a pivotal role in aligning clinical strategies with regulatory standards, helping drive forward cutting-edge solutions in the healthcare sector. This position offers a unique chance to work on vital projects that impact patient safety and device efficacy.
KEY DUTIES AND RESPONSIBILITIES
Your duties as the Clinical Scientist – Design Controls Remediation will be varied however the key duties and responsibilities are as follows:
- Perform gap analyses of clinical evidence supporting Design Inputs, risk management files, and V&V strategies.
- Contribute to the development or updating of clinical risk-benefit analyses and post-market surveillance plans.
- Support the design of V&V protocols that incorporate clinical endpoints or simulated use testing.
- Collaborate with Clinical and Pre-Clinical SMEs to align non-clinical and clinical data with design control elements.
- As the Clinical Scientist – Design Controls Remediation, you will prepare technical summaries and justifications for regulatory submissions related to clinical aspects of the Device History File (DHF).
ROLE REQUIREMENTS
To be successful in your application to this exciting role as the Clinical Scientist – Design Controls Remediation, we are looking to identify the following on your profile and past history:
- A Degree or higher level in biomedical sciences, clinical research, or a related field; clinical research certification preferred.
- Proven experience in medical device clinical science or clinical evaluation, including Design Input development and risk management.
- In-depth knowledge of ISO 14155 and FDA clinical evidence requirements.
- Experience with clinical literature reviews, data analysis, and gap remediation in DHF projects.
WHAT’S IN IT FOR YOU?
This role offers a fantastic opportunity to work remotely with a market leader in the health sciences industry. You will be involved in impactful projects, develop your expertise in a cutting-edge field, and enjoy the flexibility of remote working. Our client values professional growth and offers a collaborative, innovative environment where your contributions make a difference.
Key Words: clinical research / medical devices / regulatory compliance / clinical evidence / V&V protocols / risk management / DHF / ISO 14155 / FDA requirements / clinical evaluation / gap analysis / post-market surveillance
"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.
