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Senior Post-Market Surveillance Specialist
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Job Description
- Req#: 5762473004
Employer Industry: Medical Technology
Why consider this job opportunity:
- Estimated base salary up to $115,000 for the San Francisco Bay Area or up to $95,000 for all other locations, plus bonuses
- Opportunity for career advancement and growth within a pioneering medical technology company
- Engage in meaningful work that contributes to improved patient outcomes and safety
- Supportive and collaborative work environment with a focus on mentorship and training
- Chance to work with cutting-edge technology in the healthcare industry
- Work in a fast-paced, adaptive environment that encourages innovation and critical thinking
What to Expect (Job Responsibilities):
- Maintain accurate post-market surveillance (PMS) processes and procedures, including PMS Plans, Reports, and Periodic Safety Update Reports (PSUR)
- Ensure timely and accurate Medical Device Reporting (MDR) and adverse event reporting to regulatory authorities
- Analyze investigation data using systems such as Jira, Salesforce, and Tableau to identify trends and opportunities for product improvement
- Conduct proactive PMS activities, including web screening and customer survey reviews, to identify emerging issues
- Coordinate product field action activities, including risk assessment and corrective actions
What is Required (Qualifications):
- Bachelor's degree in Science, Engineering, or a related field
- 8+ years of relevant experience in the medical device industry, with a preference for software medical device products (class II/III)
- Deep understanding of regulatory standards including 21 CFR 820, 803, 806, and EU MDR
- Proficiency in Salesforce, Tableau, Electronic Document Management Systems (EDMS), and MS Office
- Strong critical thinking skills and great attention to detail
How to Stand Out (Preferred Qualifications):
- Experience with Health Hazard Evaluations (HHE) and risk management activities
- Familiarity with ISO 13485 and ISO 14971 standards
- Background in mentoring or training team members and cross-functional stakeholders
- Ability to stay current with global regulatory requirements and industry best practices
- Experience in optimizing surveillance workflows for efficiency
#MedicalTechnology #HealthcareInnovation #CareerOpportunity #RegulatoryCompliance #DataAnalysis
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