Back to Job SearchROLE OVERVIEW
We are currently looking for a Risk Management Lead to join a leading medical device company based remotely in the US. An exciting opportunity for a seasoned professional to contribute to the enhancement of risk management processes within a dynamic and regulated environment. This role offers the chance to lead critical remediation initiatives that will bolster regulatory compliance and improve organisational risk strategies.
As the Risk Management Lead, you will play a pivotal part in refining the company's risk framework, ensuring it aligns with industry standards and regulatory expectations to support product safety and effectiveness.
KEY DUTIES AND RESPONSIBILITIES
Your duties as the Risk Management Lead will be varied however the key duties and responsibilities are as follows:
- Lead system-level risk management remediation initiatives to address gaps in risk integration, escalation, and decision-making across the organisation.
- Conduct assessments of the risk management framework to identify structural gaps and develop remediation strategies aligned with regulatory expectations.
- Serve as the subject matter expert for ISO 14971, ensuring consistent interpretation and application of risk management principles across design and post-market activities.
- Strengthen integration of risk management outputs into QMS processes such as Management Review, CAPA, change control, and governance decision-making.
- As the Risk Management Lead, you will ensure compliance with relevant standards and support continuous improvement in risk management practices.
ROLE REQUIREMENTS
To be successful in your application to this exciting role as the Risk Management Lead we are looking to identify the following on your profile and past history:
- A Degree or higher level in a related field.
- Extensive industry experience in medical device risk management within a regulated environment.
- A working knowledge and practical experience with ISO 14971 risk management, including application across design controls and post-market risk activities.
WHAT’S IN IT FOR YOU?
- Opportunity to lead critical risk management projects within a globally recognised organisation.
- Remote working flexibility to support work-life balance.
- Competitive benefits package and career development prospects within the life sciences sector.
Key Words: Risk Management / Medical Device / ISO 14971 / QMS / CAPA / Regulatory Compliance / Risk Remediation / FDA / Post-Market Surveillance / Governance
"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.
