MDR Specialist

About the role

This is a remote position. PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. The Experience With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you decide join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.

Responsibilities

• 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.

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.

Benefits

W2 temp roles include our Medical and Sick Time benefits.

Pay

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.

Schedule

This is a full-time, 3 month contract remote role, with the potential to extend after the initial contract end date.