Senior Specialist - Medical Events Group

Abbott • Alameda, CA

7d • $90,000 - $180,000 • Onsite

About The Position

This position works out of our Alameda, CA location in the Diabetes Care division where we're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. As Medical Events Group Senior Specialist, you will be responsible for timely review, documentation and filing of Medical Device Reports to the FDA (US), Medical Problem Reports to Health Canada, Medical Incident Reports to the EU/EFTA including France, and Medical Device Incident reports to the rest of world for the division's products.

Requirements

• Bachelors Degree in related field or an equivalent combination of education and work experience; Associates Degree with minimum 8 yrs of industry experience will also be accepted
• Minimum of 5 years of experience in Regulatory experience required.

Nice To Haves

• Ability to communicate at all levels with clarity and precision both written and verbally.
• Excellent problem-solving and critical-thinking skills.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Multitasks, prioritizes and meets deadlines in timely manner.

Responsibilities

• Review medical complaints and potentially reportable events, gather required additional information to determine the reportability of the complaint in accordance with regulations.
• Document filing decision rationale in the Complaint Handling System.
• Ensure timely submission of reportable medical events and malfunctions to regulatory authorities in accordance with local and international regulations.
• Monitor the status of submitted vigilance reports and ensure follow–up actions are completed in timely manner.
• Collaborate with internal teams such as customer service, Complaint evaluation group and complaint investigation team to gather necessary information for vigilance reports.
• Provide feedback and recommend solutions within the Quality team to promote accurate documentation of the complaint case.
• Adapt processes and documentation to align with updated regulations.
• Interface with management and other functional areas to ensure that Potential Reportable Events (PREs) are obtained in a timely and consistent basis.
• Demonstrates subject matter expertise; provide guidance, and training to other members of the Medical Events Group as well as to other functional departments.
• Drive improvements to standard operating procedures, training and other tools used by for the Medical Events Group as required.

Benefits

• Free medical coverage for employees via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement
• the Freedom 2 Save student debt program
• FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior