Regulatory Assurance/Quality Assurance Specialist
1 week ago
We are seeking a highly experienced Regulatory Assurance/Quality Assurance Specialist to join our team at NextPhase Medical Devices LLC. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring our medical devices meet international regulatory standards and quality requirements.
Key Responsibilities- Regulatory Compliance
- Ensure compliance with international regulatory requirements, including FDA, EU MDR, Health Canada, and 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.
- Sterilization Oversight
- Oversee sterilization processes to ensure compliance with ISO 11135, ISO 11137, and other relevant standards.
- Coordinate and review validation and re-validation activities for sterilization processes.
- Develop and maintain sterilization procedures and protocols.
- Liaise with sterilization service providers to ensure compliance with regulatory and quality requirements.
- Quality Management System (QMS)
- Support the development, implementation, and maintenance of the QMS in accordance with ISO 13485.
- Support internal audits to ensure compliance with QMS requirements.
- Lead continuous improvement initiatives within the QMS framework.
- Product Lifecycle Management
- Oversee regulatory aspects throughout the product lifecycle from development through post-market.
- Coordinate risk management activities in accordance with ISO 14971.
- Ensure proper documentation and validation of manufacturing and sterilization processes.
- Audits and Inspections
- Prepare for and manage external audits and inspections by regulatory bodies.
- Implement corrective and preventive actions (CAPA) as needed.
- Maintain audit readiness and compliance with regulatory standards.
- Supplier and Vendor Management
- Support the evaluation, qualification, and monitoring of suppliers and vendors to ensure compliance with quality and regulatory standards.
- Support oversight supplier audits and supplier quality performance, inclusive of sterilization service providers.
- Develop and maintain supplier quality agreements.
- Training and Mentorship
- Provide training and support to staff on quality and regulatory requirements.
- Mentor junior associates regarding the quality/regulatory affairs discipline.
- Promote a culture of regulatory compliance and quality assurance across the organization.
- 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.
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