MDR Specialist

Your Role: We are seeking an experienced MDR Specialist to support post-market quality activities for medical devices. This individual will be responsible for evaluating complaints, assessing regulatory reporting requirements, supporting adverse event investigations, and ensuring compliance with applicable quality system and regulatory standards. The ideal candidate has experience in complaint handling, Medical Device Reporting (MDR), and post-market surveillance within a regulated medical device environment. This is a full-time, 3 month contract remote role, with the potential to extend after the initial contract end date. Review and assess product complaints in accordance with company procedures and regulatory requirements. Evaluate complaint events for reportability and potential patient safety impact on designated medical device system. Prepare and submit Medical Device Reports (MDRs) and related regulatory documentation. Conduct or support complaint investigations and ensure timely documentation and closure of records. Collaborate with cross-functional teams, including Quality, Regulatory Affairs, Engineering, Manufacturing, and Clinical personnel, to gather and evaluate information. Support post-market surveillance activities and trending efforts. Maintain accurate and compliant records within electronic quality management systems (eQMS). Contribute to continuous improvement initiatives related to complaint handling and regulatory compliance. Ensure activities are performed in accordance with FDA regulations, ISO standards, and internal quality system requirements.

Requirements: Bachelor's degree in a scientific, engineering, healthcare, or related discipline, or equivalent experience. 5+ years of experience in medical device complaint handling, vigilance, post-market surveillance, or quality assurance. Experience authoring and submitting Medical Device Reports (MDRs) and assessing regulatory reportability. Knowledge of FDA medical device regulations, including 21 CFR Part 803 and 21 CFR Part 820, as well as ISO 13485. Experience conducting complaint investigations and supporting risk-based decision making. Familiarity with electronic quality management systems (eQMS) and complaint management tools. Strong technical writing, communication, and analytical skills. Ability to work independently in a fast-paced, highly regulated environment.

Preferred Qualifications: Experience supporting Class II or Class III medical devices. Previous experience in post-market surveillance, complaint trending, or device vigilance programs. Working knowledge of risk management principles and adverse event reporting processes. W2 temp roles include our Medical and Sick Time benefits. The hourly bracket for this role is set between $35 - $38.25 hourly. The rate offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience. Equal Opportunity Employment Statement PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.