Senior Quality and Regulatory Engineer

Position Overview

Senior Quality and Regulatory Engineer

Key Responsibilities

• Quality Management Systems (QMS):

• Maintain and improve QMS in compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable standards.
• Lead internal audits and support external regulatory inspections.
• Drive CAPA, risk management (ISO 14971), and process validation activities.
• Support supplier qualification, incoming inspection, and manufacturing quality assurance.
• Investigate non-conformances and customer complaints, ensuring effective root cause analysis and corrective actions.
  

• Regulatory Affairs:

• Prepare and submit regulatory filings (510(k), CE Mark Technical Files, MDR submissions, etc.).
• Monitor changes in global regulatory requirements and assess impact on company products.
• Collaborate with cross-functional teams to ensure design controls, verification/validation, and usability engineering meet regulatory expectations.
• Maintain regulatory documentation including DHF, DMR, DHR, and ensure readiness for audits.
• Act as liaison with regulatory authorities, notified bodies, and certification agencies
  

• Product Development Support:

• Collaborate with R&D teams to ensure design controls, risk analysis, and verification/validation activities meet regulatory expectations.
• Review and approve design history files (DHF), device master records (DMR), and device history records (DHR).

• Supplier & Manufacturing Quality:

• Evaluate and qualify suppliers to ensure compliance with quality standards.
• Support process validation, equipment qualification, and production line quality assurance.
• Lead investigations into non-conformances and customer complaints.

• Training & Leadership:

• Provide guidance and training on regulatory and quality requirements to cross-functional teams.
• Mentor junior engineers and contribute to building a culture of compliance and continuous improvement.

Qualifications

• Bachelors or Master’s degree in Engineering, Biomedical Engineering, or related field.
• 3–5 years of experience in quality and regulatory roles within the medical device industry.
• Strong knowledge of ISO 13485, FDA QSR, EU MDR, and international regulatory frameworks.
• Experience with regulatory submissions (510(k), CE Mark, MDR).
• Excellent analytical, problem-solving, and communication skills.
• Ability to work cross-functionally and manage multiple projects simultaneously.

Preferred Skills

• Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or RAC certification. (?)
• Experience with risk management standards (ISO 14971) and usability engineering (IEC 62366).
• Familiarity with software as a medical device (SaMD) and cybersecurity regulations.
• Prior experience in supporting global markets (US, EU, APAC).