Sr. Post-Market Surveillance Specialist (Contract)

Job Id: 263250

Sr. Post-Market Surveillance Specialist (Contract)

Location: Onsite – San Diego CA

Duration: 8 – 10 weeks
Schedule: Monday–Friday | 8:00 AM – 5:00 PM
Pay Rate: $35–$45 per hour
Assignment Type: Short-term contract (ideal for consultants or professionals open to contract work)

About the Role

We are seeking a Senior Post-Market Surveillance Specialist to support regulatory and compliance activities related to medical device customer complaints and adverse event reporting. This onsite contract role plays a critical part in ensuring timely accurate and compliant handling of post-market surveillance activities in alignment with global regulatory requirements.

This opportunity is well-suited for experienced medical device professionals who enjoy hands-on work cross-functional collaboration and short-term high-impact assignments.

What You’ll Do

• Manage post-market compliance activities including customer complaints adverse event reporting and medical device reports (MDRs)

• Review evaluate investigate document and close complaints within required timelines

• Perform preliminary complaint investigations including follow-up with healthcare professionals

• Prepare submit and track adverse event reports to regulatory authorities in accordance with regional requirements

• Escalate product-related issues to Engineering and Supply Chain teams as needed

• Compile investigation findings document root cause analyses apply event codes and route reports for approval

• Drive complaint investigation progress reporting accuracy and on-time closure

• Communicate investigation outcomes clearly to internal stakeholders and external customers

• Monitor complaint and adverse event trends and escalate findings appropriately

• Collaborate cross-functionally with Supply Chain Engineering Product Design Commercial and other teams

• Participate in training continuous regulatory compliance education and process improvement initiatives

What You’ll Need

• Bachelor’s degree in Life Sciences or a related field (or equivalent experience)

• 5+ years of experience in the medical device industry

• 1+ year of hands-on experience managing and closing product complaints

• Strong working knowledge of:

  • FDA 21 CFR Part 803 (Medical Device Reporting)

  • FDA 21 CFR Part 820.198 (Complaint Files)

  • Global regulatory requirements (EU MDSAP and other regions)

• Solid understanding of quality systems regulations and good documentation practices

• Ability to analyze data identify root cause and draw sound conclusions

• Comfortable engaging with clinicians and understanding clinical environments

• Ability to manage real-time customer feedback and resolve or route inquiries efficiently

• Fluent in English and Spanish a plus; additional languages also a plus