Complaint Handler

About USDM

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM's clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

Nature and Scope of Job

Responsible for the end-to-end lifecycle processing of product complaints and regulatory assessment activities for Class II/III neurovascular medical devices, ensuring compliance with domestic and international regulatory requirements and corporate objectives. Under minimal supervision, ensure that all complaint handling tasks - from intake, documentation, investigation, regulatory decision-making, to closure - are completed accurately, timely, and in compliance with internal procedures and external industry regulations. Work closely with Field Assurance (FA) management to help drive continuous improvement activities. Interact with field sales representatives, hospital staff, distributors, manufacturing facilities.

Primary Responsibilities

Complaint Intake & Documentation

• Receive, document, and triage product complaints from domestic and international customers across multiple intake channels (phone, email, CRM, service reports).
• Analyze complaints to determine if they meet the regulatory definition of a complaint.
• Collect and validate all necessary data elements, including device identifiers, event description, patient outcome, reporter information, and usage context.
• Ensure complaint records are entered into the electronic complaint handling system in compliance with Good Documentation Practices (GDP) and company procedures.

Complaint Coding & Preliminary Risk Assessment

• Assign internal complaint codes and patient outcome codes based on the complaint narrative and event context.
• Conduct initial risk evaluation to determine potential for harm and assist in the triage of high-risk cases for expedited handling.

Regulatory Assessment & Reporting

• Analyze complaints to determine reportability in accordance with global regulations including FDA MDR (21 CFR 803), EU MDR (2017/745), MEDDEV guidelines, Health Canada MDR (SOR/98-282), TGA, and others.
• Construct regulatory decision-making rationales using applicable guidance and decision trees.
• Prepare and submit eMDRs and Vigilance reports to the appropriate Regulatory Authority or Authorized Representative within mandated timelines.
• Assist in drafting responses to regulatory inquiries and provide additional data upon request.

Complaint Investigation

• Collaborate with internal stakeholders (e.g., Quality Engineering, R&D, Manufacturing, Failure Analysis Lab) to conduct and document thorough investigations.
• Coordinate retrieval and analysis of returned products when applicable.
• Ensure all findings, root cause evaluations, and supporting data are clearly captured within the complaint record.

Customer Communication

• Draft and issue clear, professional customer response letters, summarizing investigation outcomes, root cause (if known), and any corrective actions taken.
• Respond to follow-up questions or requests for additional information from customers, field staff, or clinical users.

CAPA & Continuous Improvement

• Identify potential trends or recurring issues that may require CAPA initiation.
• Participate in or support root cause investigations and CAPA actions related to complaint findings.
• Contribute to improvements in product design, labeling, instructions for use, or manufacturing processes based on complaint data.

Complaint Closure & Quality Review

• Ensure complaint files are completed, reviewed, and closed in a timely and compliant manner, with all required documentation and justification.
• Perform quality checks of complaint records to verify consistency, accuracy, and completeness.
• Track open complaints and actively work to eliminate backlog and aging files.
• Audit Readiness & Documentation
• Maintain accurate and audit-ready documentation for complaint records and regulatory reports.
• Support internal, external, and regulatory inspections by providing records, explanations, and documentation as needed.

Procedural Support & Compliance

• Assist in drafting, reviewing, and updating complaint handling procedures, work instructions, and templates.
• Stay current on changes in applicable regulations and standards (e.g., ISO 13485, FDA QSR, EU MDR).
• Ensure adherence to all company quality system procedures, policies, and ethical standards.

Additional Responsibilities

• Performs other related duties and assignments as required

Qualifications

• Minimum 8 years of complaint handling or post-market surveillance experience, including 5+ years in preparing and submitting eMDRs/Vigilance reports for Class II/III medical devices.
• Experience working in a post-market, analytical, or regulatory role with medical devices in clinical/healthcare settings (endovascular, cardiovascular, surgical, or neurological).
• Perform other complaint-related or post-market surveillance tasks as required by management.
• Experience evaluating complaints involving vascular, implantable, or neurological interventional medical devices.
• In-depth knowledge of global adverse event reporting requirements for Class II/III medical devices.
• Strong analytical, time management, and prioritization skills under compliance deadlines.
• Excellent critical thinking and decision-making abilities supported by objective data.
• Superior writing skills for drafting clear, concise clinical/technical summaries.
• Effective interpersonal and communication skills; ability to work cross-functionally.
• Proficient in MS Word, Excel, Outlook, Teams, and Adobe Acrobat.

Education & Certifications

• Bachelor's degree or equivalent combination of education and experience.

Working Conditions

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

Unless reasonable accommodations can be made, while performing this job the staff member shall:

• Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
• Operate other office productivity machinery, such as a calculator, scanner, or printer.
• Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.

Equal Opportunity Statement

USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Compensation

Salary/Hourly Rate Range (W2): USD 35.00 - 45.00

The base salary/hourly rate range represents the anticipated low and high end of the USDM's compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate's qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.

Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.

Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part-time employees may be eligible for paid time off.

All employees are eligible for USDM's rewards and recognition program.

For more details about our benefits, visit us here: https://usdm.com/careers