Overview In this role you support Abbott's Product Surveillance by guiding global medical device reporting and complaint investigations. You operate as a clinical expert, ensuring timely MDR submissions and cross-functional collaboration to uphold regulatory requirements. You train peers, assist inspections, and drive escalation decisions to maintain device safety and quality. This position sits at the intersection of clinical know-how and regulatory compliance, offering impact across global reporting and customer-facing investigations.
Responsibilities- File global medical device reports within regulatory timeframes with oversight from the department manager
- Represent Product Surveillance in cross-functional meetings and lead in the manager's absence
- Train new hires on complaint handling and maintain training documentation
- Provide training on complaint reporting to other groups as required
- Maintains and ensures completeness of complaint information
- Support regulatory inspections (e.g., FDA, TUV) as needed
- Coach and guide team members on product complaint investigations
- Independently conduct investigations with customers or field staff using product knowledge
- Make sound decisions on medical device reporting to global regulatory agencies
- Determine when additional support is needed from other teams for investigations
- Support Company initiatives related to QMS, EMS, and regulatory requirements
- Ensure compliance with FDA regulations, policies, procedures and task assignments
- Foster positive, cooperative communication across all levels of employees, customers, contractors, and vendors
- Undertake other related duties as required
Key requirements- Four-year degree or a 2-year degree with relevant experience
- Strong verbal and written communication
- Critical thinking and problem-solving with attention to detail
- Proficient computer skills
- Ability to work independently and in a team in a fast-paced environment
- Knowledge of global regulations for medical device reporting and complaint handling (preferred)
- Minimum 3 years of experience
- Strong communication skills
- Critical thinking
- Attention to detail
- Knowledge of global medical device reporting regulations
- Complaint handling processes
- Regulatory inspections (FDA, ISO) familiarity
