Job Description: Senior Quality and Regulatory Engineer

Position Overview

The Senior Quality and Regulatory Engineer will play a critical role in ensuring that medical devices meet global regulatory requirements and adhere to the highest standards of quality. This position involves leading quality system initiatives, managing regulatory submissions, and supporting product development teams to ensure compliance with ISO, FDA, and other international standards.

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).