Senior Medical Device Vigilance & Data Analytics Analyst

The Fountain Group; Alameda (CA); On-site; USD 76,000 - 81,000; Part time

Job summary

The Fountain Group is seeking a skilled professional for a 6-month contract in Alameda, CA, onsite only. This role focuses on independently handling complex medical device complaints, ensuring regulatory compliance, and driving data-driven improvements.

Responsibilities include leading investigations, supporting CAPA and adverse event activities, and developing dashboards and metrics to monitor quality systems. A strong regulatory background and data analytics are essential.

Qualifications

• Bachelor's degree required.
• 5–8+ years of medical device complaint handling or post-market surveillance experience.
• Strong knowledge of 21 CFR Part 820, Part 803, ISO 13485, ISO 14971, EU MDR, and related QMS.
• Experience independently evaluating, investigating, documenting, and closing complex complaints.
• Experience supporting adverse event reporting, CAPA activities, and regulatory decision making.
• Strong data analytics skills with experience analyzing large datasets.

Responsibilities

• Independently evaluate, investigate, document, and close complex medical device complaint records.
• Serve as SME for complaint handling procedures, closure decisions, and regulatory requirements.
• Support global vigilance reporting and adverse event reporting.
• Perform quality reviews of complaint files for compliance, accuracy, and data integrity.
• Analyze large complaint datasets to identify trends and drive data-based decisions.
• Develop metrics, dashboards, and tools to monitor Quality System performance.
• Utilize SQL and databases to extract and interpret complaint data.
• Support CAPA investigations, risk management, and continuous improvement.
• Author, revise, and redline complaint procedures and training materials.
• Provide guidance to complaint evaluation and closure teams and collaborate cross-functionally.

Skills

Medical device complaint handling

Data analytics

Regulatory knowledge

Cross-functional collaboration

Mentorship

Education

Bachelor's degree

Tools

SQL

Databases

Job description

The Fountain Group is seeking a skilled professional for a 6-month contract in Alameda, CA, onsite only. This role focuses on independently handling complex medical device complaints, ensuring regulatory compliance, and driving data-driven improvements.

Responsibilities include leading investigations, supporting CAPA and adverse event activities, and developing dashboards and metrics to monitor quality systems. A strong regulatory background and data analytics are essential.