Back to Job SearchROLE OVERVIEW
We are currently looking for a Risk Management Specialist – Design Controls Remediation to join a leading medical device company based in the US. This is an exciting opportunity for a dedicated professional to contribute to critical risk management activities within a dynamic industry environment. The successful candidate will play a key role in ensuring quality and safety standards are upheld through meticulous risk assessments and documentation review.
As a vital part of our client's team, you will be involved in supporting various remediation workstreams that enhance product safety and compliance. This role offers the chance to work within a collaborative, innovative setting where your expertise will influence essential outcomes in medical device development.
KEY DUTIES AND RESPONSIBILITIES
Your duties as the Risk Management Specialist will be varied; however, the key duties and responsibilities are as follows:
• Provide risk management expertise across remediation workstreams to ensure compliance and product safety.
• Review design documentation to verify appropriate consideration and evaluation of product risks.
• Support retrospective evaluations of risk within existing design documentation to identify gaps and improvements.
• Assist in the development of risk-based justifications where documentation gaps exist, ensuring alignment with industry standards.
• As the Risk Management Specialist, you will collaborate effectively with cross-functional teams to drive risk mitigation strategies and documentation updates.
ROLE REQUIREMENTS
To be successful in your application to this exciting role as the Risk Management Specialist, we are looking to identify the following on your profile and past history:
• A Degree or higher level in a related field (e.g., Biomedical Engineering / Quality Assurance / Life Sciences).
• Proven industry experience in risk management within medical device development, with a strong understanding of design controls.
• A working knowledge and practical experience with ISO 14971 and FDA QMSR risk management expectations.
WHAT’S IN IT FOR YOU?
Joining our client provides an opportunity to work on impactful projects within a leading organization dedicated to advancing healthcare technologies. You will be part of a forward-thinking team that values expertise and innovation, with potential for career growth and development in a highly regulated industry.
Key Words: Risk Management Specialist / Design Controls Remediation / medical device development / remediation workstreams / ISO 14971 / FDA QMSR / risk-based justifications / cross-functional teams / product risk / documentation updates
"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.
