Our client, a medical device manufacturing company, has an immediate opening for a Senior Regulatory/Quality Assurance Specialist. This role will oversee regulatory compliance activities, manage documentation for product approvals, and ensure adherence to global regulatory standards, including ISO 13485:2016, FDA 21 CFR and sterilization standards.

Responsibilities:

• Ensure compliance with international regulatory requirements (e.g., FDA, EU MDR, Health Canada, TGA)
• Prepare and submit regulatory documentation and registrations for product approvals
• Maintain current knowledge of relevant regulatory requirements, including sterilization standards and industry best practices
• Review and approve regulatory submissions and documentation for accuracy and completeness
• Oversee sterilization processes to ensure compliance with ISO 11135, ISO 11137, and other relevant standards
• Develop and maintain sterilization procedures and protocols
• Support the development, implementation, and maintenance of the QMS in accordance with ISO 13485
• Support internal audits to ensure compliance with QMS requirements
• Oversee regulatory aspects throughout the product lifecycle from development through post-market
• Coordinate risk management activities in accordance with ISO 14971
• Prepare for and manage external audits and inspections by regulatory bodies
• Support the evaluation, qualification, and monitoring of suppliers and vendors to ensure compliance with quality and regulatory standards
• Provide training and support to staff on quality and regulatory requirements
• Other responsibilities as required

Requirements:

• Bachelor’s degree in Engineering, Life Sciences, or a related field; advanced degree favorable
• Minimum of 7-10 years of experience in regulatory affairs in the medical device industry, with a focus on sterilization processes
• In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR, and other relevant international standards and regulations
• Proven experience in leading internal and external audits
• Strong understanding of sterilization standards (ISO 11135, ISO 11137) and risk management principles (ISO 14971)
• Excellent communication, organizational, and analytical skills
• Ability to work effectively in a fast-paced, dynamic environment
• Certification in quality management or regulatory affairs (e.g., CQE, RAC) is favorable
• This position requires 100% on-site attendance