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Quality & Regulatory Engineer

4 weeks ago

Plainview, New York, United States LHH Full time

We are looking for a motivated Entry-Level Quality & Regulatory Engineer to join our team and support quality assurance and regulatory compliance efforts for medical devices such as ECG, blood pressure monitoring systems, and ECP (External Counterpulsation) systems. This role involves assisting with regulatory submissions, compliance audits, and quality control processes to ensure adherence to FDA, ISO 13485, and other global regulations.

Key Responsibilities

Regulatory Affairs:

  • Assist in preparing and maintaining regulatory submissions (e.g., 510(k), CE Mark, FDA registrations, and international approvals) for medical devices.
  • Research and interpret regulatory requirements (FDA, MDR, ISO 13485, IEC 60601) to support product compliance.
  • Support internal and external regulatory audits and inspections.
  • Ensure product labeling, user manuals, and technical documentation meet regulatory standards.

Quality Assurance & Compliance:

  • Help implement and maintain the Quality Management System (QMS) in accordance with ISO 13485 and FDA 21 CFR Part 820.
  • Participate in CAPA (Corrective and Preventive Actions), non-conformance investigations, and root cause analysis.
  • Assist in conducting supplier quality audits, including overseas manufacturing facilities.
  • Review and maintain Device Master Records (DMR), Design History Files (DHF), and Risk Management Files (ISO 14971).
  • Collaborate with manufacturing and R&D teams to support design changes, risk assessments, and process validation.

Qualifications

Education:

  • Bachelor's degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a related field.

Skills & Experience:

  • Strong analytical, problem-solving, and organizational skills.
  • Ability to work effectively in a cross-functional team and collaborate with overseas manufacturers.
  • Proficiency in Microsoft Office (Word, Excel, PowerPoint, OneDrive, SharePoint).
  • Knowledge of medical device regulations (FDA 510(k), MDR, ISO 13485, IEC 60601) is a plus.
  • Experience with quality management software is a plus.