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Finish Line Staffing Services
Published
October 21, 2024
Location
Foxborough, MA
Category
Job Type

Description

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
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