Job Title: Senior Medical Device Complaint Handling / Post-Market Surveillance Specialist
Company: Intellectt
Location: Alameda, CA
Duration: Long Term
Working Hours: 8:00 AM 4:30 PM
Job Summary:
Intellectt is seeking an experienced Medical Device Complaint Handling Specialist to manage complex product complaints and post-market surveillance activities. The ideal candidate will have 5 8+ years of medical device complaint handling experience, strong knowledge of FDA and international regulatory requirements, and advanced data analytics skills. The role involves complaint investigations, adverse event reporting, CAPA support, complaint trending, risk assessments, and developing quality metrics and dashboards to ensure regulatory compliance and continuous improvement.
Key Responsibilities:
- Independently investigate, evaluate, document, and close complex medical device complaints.
- Ensure complaint records meet regulatory requirements, documentation standards, and data integrity expectations.
- Support global vigilance, adverse event reporting, and regulatory reportability assessments.
- Analyze complaint and post-market surveillance data to identify trends, emerging risks, and product performance issues.
- Develop and maintain quality metrics, dashboards, and reports for management reviews and regulatory compliance.
- Use SQL, Excel, databases, and analytical tools to extract, analyze, and interpret complaint data.
- Support CAPA investigations, risk management, signal detection, and continuous improvement activities.
Required Qualifications:
- 5 8+ years of experience in medical device complaint handling or post-market surveillance.
- Strong knowledge of 21 CFR Part 820, Complaint Files (198), 21 CFR Part 803, ISO 13485, ISO 14971, and EU MDR.
- Experience independently investigating, evaluating, documenting, and closing complex medical device complaints.
- Experience with adverse event reporting, CAPA, complaint trending, risk assessments, and regulatory decision-making.
- Strong data analytics skills with experience analyzing large datasets and identifying trends and emerging risks.
- Advanced Microsoft Excel skills, including pivot tables, advanced formulas, Power Query, and data modeling.
- Experience with SQL, databases, Salesforce, complaint handling systems, and electronic Quality Management Systems (eQMS).
- Experience developing quality metrics, dashboards, and management reports.
- Strong technical writing, documentation, communication, analytical, and problem-solving skills.
Preferred Qualifications:
- Experience with statistical analysis, data visualization, and business intelligence tools.
- Experience developing reporting tools and dashboards for post-market surveillance and quality system monitoring.
- Experience supporting global regulatory inspections, audits, and health authority inquiries.
- Experience leading post-market surveillance initiatives and process improvement projects.
- Ability to provide technical guidance and mentorship to complaint handling teams.
Pay Range: $45-50/hr On W2
Benefits:
- Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:
- Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.
- Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
- Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.
Equal Employment Opportunity:
Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.