RAQA Post Market Complaint Specialist - 26508

Our client, a Global Leader in the Medical Device Industry has an immediate opening for a RAQA Post Market Complaint Specialist for a 6-month Contract.  Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed, and detail-oriented Top Talents in an extremely collaborative and professional environment.  

Responsibilities

• Investigating and evaluating product complaints and adverse events through collaboration with clinical, quality, and engineering teams.
• Collecting, reviewing, and analyzing post-market surveillance data to identify trends, potential risks, and areas for improvement.
• Generating and submitting complaint reports, MDRs (Medical Device Reports), and other regulatory documentation per FDA and global requirements.
• Coordinating with Quality Assurance to ensure compliance with global regulatory guidelines (FDA, MDR, ISO 13485, etc.).
• Documenting detailed investigations and findings in complaint handling systems.
• Supporting audits and inspections related to post-market activities.
• Providing input on risk management and root cause analysis based on field performance.
• Collaborating with cross-functional teams, including Regulatory Affairs, Engineering, and Clinical teams.
• Monitoring ongoing product safety and tracking corrective or preventive actions (CAPAs) as necessary.

Maintaining up-to-date knowledge of medical device regulations and guidance for post-market surveillance

Requirements

• You must be a licensed Registered Nurse (RN) with at least 5 years of professional nursing experience.
• Strong attention to detail, with a demonstrated ability to manage complex documentation accurately.
• At least 2 years of experience working in a Quality Assurance (QA) role, preferably in a regulated industry such as medical devices or healthcare.
• Experience working in medical device or pharmaceutical industries.
• Familiarity with complaint handling systems (TrackWise, etc.).
• Knowledge of regulatory reporting requirements (MDR, FDA 21 CFR 803, EU MDR, etc.).
• Background in clinical or nursing practice preferred.