Be a part of a global team where what we do matters! At Epredia, we recognize that our talented employees are vital to our success. Our team is dedicated, our work is rewarding – both personally and professionally – because what we do matters. 

　　We seek talented individuals who will contribute to and thrive in our collaborative, diverse, fast-paced environment while demonstrating a commitment to our core values, People, Customer, Results, Continuous Learning, and Innovation. 

　　People – We win as a team. 

　　Customer – We deliver customer-centric solutions. 

　　Continuous Learning – We learn and always aim to be better. 

　　Innovation – We innovate every day. 

　　Results – Results matter for all of us.

　　Exciting Opportunity in Healthcare Technology!

　　Position: Risk Management Specialist – Medical Devices

　　Are you ready to contribute to the future of healthcare technology? Epredia is seeking a talented and dedicated Risk Management Specialist to join our team. As a key player in our organization, you will be at the forefront of ensuring compliance with medical standards and driving excellence in risk management practices.

　　Responsibilities:

　　Comprehensive Risk Management:

　　Lead risk management activities, incorporating applicable medical standards to ensure product safety and efficacy.

　　Perform and support risk analysis following ISO14971:2019 guidelines, including Hazard Analysis, FMEAs, and FTAs.

　　Design Control Compliance:

　　Identify and manage Essential Design Outputs, Critical to Quality (CTQs), and Product Critical Components.

　　Influence development decisions by assessing risks within new design proposals.

　　Documentation and Regulatory Compliance:

　　Follow design control processes diligently while generating and reviewing risk management deliverables.

　　Ensure effective implementation of risk control measures, suitable for regulatory submissions.

　　Conduct Risk/Benefit analysis for existing and newly identified residual risks.

　　Post Market Surveillance:

　　Conduct required Risk Management File (RMF) reviews and stay abreast of the industry's state-of-the-art status for Post Market Surveillance activities.

　　Collaborate with Sourcing and Supplier Quality teams to ensure delivered products align with the risk strategy.

　　Continuous Improvement:

　　Participate in complaints reviews and root cause analyses, applying tools such as 5Why and Ishikawa, for appropriate risk evaluations and controls.

　　Contribute to investigations of non-conformities (NCRs) and corrective and preventive actions (CAPAs) related to products and processes.

　　Certification Audits:

　　Act as the Subject Matter Expert (SME) for Risk Management during certification audits, particularly in ISO13485.Qualifications:

　　A degree in life science or engineering discipline.

　　Experience in Risk Management to ISO14971:2019 in the IVD/MD Medical Devices industry.

　　In-depth knowledge of 21 CFR 820, 21 CFR 11, and ISO 13485:2016 associated with the medical device industry.

　　Understanding and experience with Design Controls.

　　Strong interpersonal skills, ability to collaborate in multi-disciplinary teams, influence decision-making, and build group consensus.

　　Excellent written and oral communication skills.

　　Join us in making a difference in healthcare technology! Apply now and be part of our commitment to excellence and innovation.

　　TO ALL RECRUITMENT AGENCIES: Epredia does not accept unsolicited third-party resumes.

　　Building an Inclusive Culture: We are a company that brings varying backgrounds, ideas, and points of view to inventing on behalf of all customers. Our diverse perspectives are enriched by many dimensions, including race, ethnicity, gender, age, physical and mental ability, sexual orientation, religious beliefs, culture, language, and education, as well as professional and life experience. We are committed to diversity, equity, and inclusion, and leveraging our unique perspectives to scale our impact and growth.

　　At Epredia, we improve lives by enabling better cancer diagnostics. We are a team of talented individuals with diverse backgrounds and expertise, working together to develop precision diagnostic solutions for our customers. We are a fast growing global company that drives innovation in diagnostics to create better outcomes for patients. Joining Epredia is much more than a job- it is an opportunity to be part of something with a purpose. Find out how you can improve lives while advancing your career.