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Regulatory Compliance Auditor

2 months ago

Fremont, California, United States Abbott Full time

The Opportunity

This role involves conducting internal quality assessments to ensure adherence to the standards set by regulatory bodies such as FDA, ISO, MDD, CDR, and others relevant to the Quality Management System. The position also includes participation in and support during external regulatory evaluations.

What You'll Work On

This position is situated within the Diabetes Care division, where our mission is to empower individuals with diabetes to effectively manage their health through innovative products that deliver precise data for informed decision-making. We are at the forefront of transforming glucose monitoring through advanced sensing technologies.

  • Lead and assist in divisional internal, clinical, and supplier audits to ensure timely resolution of audit findings.
  • Facilitate Audit Readiness initiatives for external evaluations, including training staff and providing guidance for preparation.
  • Aid in managing compliance gaps by identifying business risks and proposing solutions to address these issues.
  • Support the management of the near miss reporting program.
  • Monitor changes in regulations and industry standards, assessing their impact and ensuring compliance across relevant departments.
  • Prepare, review, and analyze metrics data to inform decision-making.
  • Foster a culture of quality and compliance within the division, offering training to enhance awareness.
  • Engage in compliance projects and other assigned initiatives.

Required Qualifications

  • Associate's or Bachelor's degree, or a combination of relevant education and experience.
  • For candidates with a 2- or 4-year degree, a minimum of 5 years of experience in the medical device sector and 5 years of auditing experience per ISO and/or FDA standards is required.
  • Strong writing skills are essential. Experience in a broader enterprise or cross-division business model is preferred.
  • Ability to thrive in a highly matrixed and geographically diverse environment.
  • Capacity to work collaboratively within a team as well as independently in a dynamic setting.
  • Proficiency in engaging others to achieve project goals. Excellent verbal and written communication skills, with the ability to effectively interact at various organizational levels.
  • Strong organizational skills, attention to detail, and the ability to prioritize and meet deadlines.
  • Willingness to travel, including internationally.

Preferred Qualifications

  • Lead Auditor Certification for ISO 13485 or 9001:2000 is preferred.