Regulatory Affairs & Quality Compliance Specialist - Medical Devices

Job Description

This role leads key Quality Assurance and Regulatory Affairs activities to maintain and continually improve the Quality Management System (QMS) for a medical device organization. The position supports preparation for MDSAP certification, drives international regulatory registrations, and ensures ongoing compliance with ISO standards, FDA Quality Management System Regulation (QMSR), and other global regulatory requirements. The Regulatory Affairs Specialist / QA-RA Lead collaborates closely with cross-functional teams to strengthen quality processes, support regulatory submissions, and oversee post-market quality activities across the product lifecycle.

Responsibilities

• Support the Quality Assurance Manager in maintaining, monitoring, and improving the Quality Management System (QMS) for medical device products.
• Lead or support activities to prepare the organization for MDSAP certification, including coordination of documentation, processes, and internal readiness assessments.
• Ensure compliance with applicable ISO standards, FDA Quality Management System Regulation (QMSR), and other relevant global regulatory requirements.
• Support and coordinate international regulatory registrations, including preparation, review, and maintenance of regulatory submissions for multiple markets.
• Partner with cross-functional teams to drive continuous improvement of quality system processes and procedures.
• Assist with FDA inspections and other regulatory authority inspections by preparing documentation, coordinating responses, and supporting on-site activities.
• Support and participate in internal and external audits, including planning, execution, and follow-up on corrective and preventive actions (CAPA).
• Lead or support complaint handling activities, including investigation, documentation, trending, and implementation of corrective actions.
• Contribute to post-market surveillance activities by collecting, analyzing, and reporting product performance and safety data.
• Support supplier quality management activities, including evaluation, qualification, and ongoing monitoring of suppliers.
• Participate in design controls and validation activities to ensure products meet regulatory and quality requirements throughout development and lifecycle.
• Promote a culture of continuous compliance and quality awareness across the organization.
• Use analytical and problem-solving skills to identify quality and regulatory issues, propose solutions, and support data-driven decision-making.
• Communicate effectively with internal stakeholders to provide regulatory and quality guidance and to ensure alignment with applicable requirements.

Essential Skills

• Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related field.
• At least 3 years of experience in medical device Quality Assurance and/or Regulatory Affairs (QA/RA).
• Hands-on experience with ISO standards applicable to medical devices and the FDA Quality Management System Regulation (QMSR).
• Experience assisting with FDA inspections and audits, including preparation and follow-up activities.
• Practical experience with corrective and preventive actions (CAPA), complaint handling, supplier quality, design controls, and validation in a medical device environment.
• Demonstrated expertise in regulatory affairs for medical devices, including understanding of global regulatory frameworks.
• Excellent analytical and problem-solving skills with the ability to make sound decisions based on data and regulatory requirements.
• Effective communication and interpersonal skills, with the ability to collaborate across cross-functional teams.
• Experience with MDSAP-related activities or requirements in a medical device setting.

Additional Skills & Qualifications

• Certification in quality such as Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Six Sigma Green Belt/Black Belt.
• Expertise with ISO 13485, ISO 14971.
• Experience with Health Canada regulatory requirements.
• Experience with ANVISA regulatory requirements.
• Experience with EU Medical Device Regulation (EU MDR).
• Experience working in a stable, established medical device organization.
• Demonstrated ability to support international regulatory registrations and maintain compliance across multiple regions.

Work Environment

The role is part of a small, focused Quality and Regulatory team of approximately four people, fostering close collaboration and shared ownership of quality and