Medical Events Section Manager

5 days ago


Alameda, California, United States Abbott Laboratories Full time
The Opportunity

We are seeking a highly skilled Medical Events Section Manager to join our team at Abbott Laboratories. As a key member of our regulatory compliance team, you will be responsible for ensuring the timely and accurate reporting of medical device events to regulatory agencies worldwide.

Key Responsibilities
  • Provide direct supervision and management to staff responsible for filing medical device reports to the FDA, Health Canada, and other regulatory agencies.
  • Ensure compliance with applicable regulations, including Quality Systems Regulations (21CFR820) and Medical Device Reporting (21CFR803).
  • Manage staff to evaluate potentially reportable complaints and ensure that reportable events are filed with worldwide regulatory agencies in compliance with regulations.
  • Anticipate, recognize, communicate, and manage quality issues within the organization.
  • Work closely with cross-functional teams to recommend actions to resolve quality issues.
Requirements
  • Bachelor's degree in a relevant field (± 16 years) or an equivalent combination of education and work experience.
  • Minimum 5 years of experience in the medical device field.
  • Minimum 3 years of management, supervisory, or team leadership experience.
  • Knowledge and experience of Quality Systems Regulations (21CFR820), Medical Device Reporting (21CFR803), and ISO standard 13485.
What We Offer

At Abbott Laboratories, we offer a competitive salary and benefits package, including a comprehensive health insurance plan, retirement savings plan, and tuition reimbursement program. We are an equal opportunity employer and welcome applications from diverse candidates.

Apply now to join our team and take the first step towards a rewarding career in regulatory compliance and quality assurance.



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