Senior Product Complaint Analyst
$71,500–$71,500 year
HybridArden Hills, Minnesota, United States
Job Summary
Conduct comprehensive investigations of customer complaints by gathering data from clinical staff, field representatives, and laboratory evaluations to determine reportability and compliance. Author and submit Medical Device Reports (MDRs), Medical Device Vigilance (MDV) submissions, and MedWatch reports in accordance with global regulatory requirements including 21 CFR Part 820, EU MDR, and ISO 13485. Apply complaint coding to support product performance trending, prepare clear written communications summarizing findings and corrective actions, and serve as a subject matter expert for regulatory reporting. Leverage data analytics to identify emerging risks and drive continuous process improvements while supporting audit readiness, CAPA investigations, and cross-functional teams. Maintain compliance with Good Manufacturing Practices and divisional SOPs to ensure patient safety and product quality.
Required Qualifications
- Associate's degree in a scientific, technical, or related field, plus relevant industry experience; or a Bachelor's degree in a scientific, technical, or related field
- Minimum of 5 years' experience in complaint handling, post-market surveillance, quality, regulatory affairs or a related function within the medical device industry
- Proficiency with Microsoft Office applications, including Word, Excel and PowerPoint
- Working knowledge and practical application of FDA, ISO and other applicable medical device regulations
- Must be able to work in our local office at least three days per week
- Must be able to work independently and collaboratively to drive compliant, timely and effective complaint handling and regulatory reporting activities
- Must be able to maintain compliance with the Quality Policy and all applicable quality system requirements, procedures and documented processes
- Must be able to provide acceptable proof of COVID-19 vaccination status
- Must be subject to a prohibited substance test
Desired Qualifications
- Experience supporting corrective and preventive action (CAPA) activities
- Experience handling complaints for medical device products
- Strong research, communication and presentation skills
- Strong technical writing, editing and documentation skills
- Demonstrated ability to adapt to changing priorities and contribute effectively in a dynamic environment
- Experience using data analytics to support quality, compliance or business decision-making
- Proven ability to influence cross-functional stakeholders and drive process improvements
- Experience presenting recommendations and project updates to leadership audiences
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