Regulatory Assurance/Quality Assurance Specialist

1 week ago


Mansfield, Massachusetts, United States NextPhase Medical Devices LLC Full time
Job Summary

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.
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.


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