[Hiring] MDR Specialist @PSC Biotech

Role Description

We are seeking an experienced MDR Specialist to support post-market quality activities for medical devices. This individual will be responsible for:

• Evaluating complaints and assessing regulatory reporting requirements.
• Supporting adverse event investigations and ensuring compliance with applicable quality system and regulatory standards.
• Reviewing and assessing product complaints in accordance with company procedures and regulatory requirements.
• Evaluating complaint events for reportability and potential patient safety impact on designated medical device system.
• Preparing and submitting Medical Device Reports (MDRs) and related regulatory documentation.
• Conducting or supporting complaint investigations and ensuring timely documentation and closure of records.
• Collaborating with cross-functional teams, including Quality, Regulatory Affairs, Engineering, Manufacturing, and Clinical personnel, to gather and evaluate information.
• Supporting post-market surveillance activities and trending efforts.
• Maintaining accurate and compliant records within electronic quality management systems (eQMS).
• Contributing to continuous improvement initiatives related to complaint handling and regulatory compliance.
• Ensuring activities are performed in accordance with FDA regulations, ISO standards, and internal quality system requirements.

Qualifications

• 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.

Requirements

• 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.

Benefits

• W2 temp roles include our Medical and Sick Time benefits.
• The salary bracket for this role is set between $75,000 - $85,000 annually. The salary offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.