What are the responsibilities and job description for the Regulatory Compliance Manager position at Abbott?
Job Summary
This is a leadership role within the Medical Events Team that requires expertise in regulatory compliance and quality systems. The ideal candidate will have a strong background in medical device reporting, complaint handling, and quality assurance.
The successful candidate will be responsible for providing direct supervision and management to staff responsible for filing medical device reports to the FDA (US), medical problem reports to Health Canada, medical incident reports to the EU/EFTA, and medical device incident reports to the rest of the world.
Duties and Responsibilities
- Ensure compliance with quality systems regulations (21CFR820) and medical device reporting (21CFR803)
- Manage staff to evaluate potentially reportable complaints in compliance with applicable regulations
- Establish processes and procedures for medical event reporting within the framework of the complaint handling system
- Work closely with customer service, complaint handling, and complaint investigation teams
The role also involves anticipating and managing quality issues within the organization and ensuring compliance with site level policies and procedures.
Qualifications
- Bachelor's degree (or equivalent)
- Knowledge and experience of quality systems regulations (21CFR820), medical device reporting (21CFR803), and ISO standard 13485
- Minimum 5 years in the medical device field
- Minimum 3 years management, supervisory, or team leadership experience required
