Regulatory Post Market Surveillance

Our Client, the pioneer of and global technology leader in robotic-assisted surgery has a Regulatory Post Market Surveillance opening in Sunnyvale, CA .

With a commitment to improving healthcare, our Client stands at the forefront, building leading-edge, integrated systems and software to provide education and support that aims to keep hospitals and their staff at the forefront of minimally invasive care.

Working at this company will provide you with a strong support system and the opportunity to make impact and grow your career.

Want to work for an innovative company that brings about transformative changes in the healthcare system world-wide? This could be the opportunity for you!

Day-to-Day Duties May Include :

• Performing the preliminary classification of complaints and escalating complaints that require additional review.
• Performing analysis investigation review and escalating complaints that require additional review.
• Filing malfunction MDR reports as identified.
• Escalating adverse event or incident reports to analysts as identified.
• Evaluating documentation for completeness and consistency, and assigning additional actions as necessary to close the complaint file.
• Approving final complaint file for closure after all applicable actions are completed.
• Managing complaint workload to required backlog goals.
• Reviewing and analyzing lot documentation (DHRs) to determine if there are any anomalies that maybe related to reported product failures.
• Escalating complaints to the Regulatory Post Market Surveillance Manager when new failure modes are encountered.
• Escalating complaints to the Post Market Investigation (PMI) group as required.
• Evaluating complaints for reporting requirements in accordance with company procedures and regulatory requirements.
• Interfacing with Customer Service and hospitals to gather additional information required for complaint investigation, including retrieval of RMA.
• Creating customer response letters.
• Providing peer review and feedback of complaints and reports.
• Participating in new hire training and continuous regulatory compliance training as required.
• Participating in process improvement activities to continuously improve process effectiveness.
• Executing on projects as required.

Qualifications :

• Bachelor’s Degree in Engineering, Life Science, or equivalent.
• 2+ years of experience in Medical Device industry.
• Knowledge and understanding with medical device complaint files and quality record documentation.
• Knowledge and understanding of regulatory reporting requirements for medical devices (US FDA requirements, EU MDD requirements, etc.)
• General technical and or clinical medical device knowledge.
• General understanding of regulatory reporting requirements for medical devices and complaint system and process requirements.
• General understanding of quality records requirements and how they apply to complaint files.
• NO C2C CANDIDATES

Interested Candidates please apply on our website at https : / / jobs.jblresources.com .

For more information about our services and great opportunities at JBL Resources, please visit our website : https : / / www.jblresources.com.

JBL Resources is proud to have earned the reputation of being a premier provider of top talent professionals in the fields of engineering, human resources, logistics, operations, and supply chain management.

As specialists in both permanent placement and contract services, our mission is to help companies and individuals become all they were created to be.

JBL is an Equal Opportunity Employer and E-Verify Company