Senior Specialist Medical Events Group Abbott Diabetes Care
Overview
Lead regulatory operations for medical device reporting across multiple regions. Own the timely submission of FDA Health Canada EU/EFTA incident reports and global compliance filings. Drive process improvements and mentor team members. This role differs by focusing on FDA and international regulatory submissions for diabetes care products.
What You'll Do11
- 1Review medical complaints and reportable events to determine filing requirements
- 2Document filing decisions using the Complaint Handling System
- 3Ensure timely submission of medical device incidents to regulatory authorities
- 4Monitor vigilance report statuses and complete follow-up actions
- 5Collaborate with customer service and complaint investigation teams
- 6Provide feedback and recommendations to enhance documentation practices
- 7Adapt processes to align with updated regulatory standards
- 8Interface with management to obtain potential reportable events
- 9Demonstrate subject matter expertise and train other team members
- 10Drive improvements to standard operating procedures and training tools
- 11Maintain accurate records of regulatory activities and outcomes
Requirements8
- 1Bachelor's degree in related field or equivalent experience
- 2Minimum 5 years regulatory experience
- 3Strong communication skills at all professional levels
- 4Excellent problem-solving and critical thinking abilities
- 5Ability to multitask and prioritize tasks effectively
- 6Experience with medical device reporting systems and regulatory frameworks
- 7Proficiency in documentation and regulatory compliance software
- 8Commitment to continuous learning and professional development
Salary Insight
Salary not disclosed in listing
Location
Required Skills
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