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Regulatory Quality Specialist

2 months ago

Woodland, California, United States ICONMA, LLC Full time

Role Overview: The Regulatory Quality Specialist is responsible for ensuring adherence to evolving regulations that impact products and processes, including but not limited to Quality System Regulations (QSR) and global import/export standards.

Key Responsibilities:

  • Manage new product introductions and oversee associated projects.
  • Collaborate with regulatory bodies on compliance initiatives, including approvals, import/export regulations, traceability, and safety assessments.
  • Act as a primary resource for customer inquiries related to regulatory and technical matters.
  • Maintain and enhance the ISO 13485 quality management system.
  • Lead the development and management of quality documentation, including Nonconformance Reports and Inspection protocols.
  • Serve as the point of contact for quality-related customer support, addressing complaints and conducting surveys.
  • Participate in customer quality audits, supplier evaluations, and regulatory inspections.
  • Conduct investigations and analyses to resolve quality-related issues.
  • Work collaboratively with cross-functional teams to implement quality systems effectively.
  • Create comprehensive product master files that meet both customer and quality system standards.
  • Ensure compliance with company policies and procedures regarding product performance and quality verification.
  • Identify, document, and investigate issues related to product, process, and quality systems.
  • Evaluate processes for potential improvements and standardization.
  • Initiate preventive actions to address non-conformance in products and processes.
  • Provide training on quality systems and relevant regulations as required.

Qualifications:

  • Bachelor's degree in a relevant field such as Science, Engineering, or Bioengineering.
  • A minimum of three years of experience in Quality or Regulatory roles, ideally within the medical device, pharmaceutical, or biotechnology sectors.
  • In-depth knowledge and practical experience with Quality Systems Regulations (21 CFR 820) and ISO standards.

Diversity and Inclusion: ICONMA, LLC is an equal opportunity employer committed to fostering an inclusive work environment that values the diverse backgrounds and abilities of all individuals, without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by applicable laws.