Regulatory Affairs Specialist II

Abbott • Lake Forest, CA

2d

About The Position

About Abbott Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together expert teams and industry‑leading technologies to support diagnostic testing that provides important information for the treatment and management of diseases and other conditions. Diagnostic testing serves as a compass, offering information that aids in the prevention, diagnosis, and treatment of a wide range of health conditions. Abbott’s tests and diagnostic tools deliver accurate, timely information to help you better manage your health. We are enabling smarter medical and economic decision‑making to help transform how people manage their health throughout life. Each day, more than 10 million tests are performed on Abbott’s diagnostic instruments, providing laboratory results for millions of people. The Opportunity The Regulatory Affairs Specialist II (Medical Events) position supports the Infectious Disease business. In this role, you will be responsible for the timely review, documentation, and submission of Medical Device Reports (MDRs), including international vigilance reports for the division’s products. You will be accountable for ensuring compliance with Medical Device Reporting regulations (including 21 CFR 803) and for the efficient and timely processing of potentially reportable events.

Requirements

• BS/BA degree in field of science such as Chemistry, Microbiology, Biology, Biochemistry or Bachelor’s Degree in Nursing, Biology, Chemistry, Biochemistry, Engineering or other related technical field (or the equivalent combination of education and experience).
• 4+ years of experience in a Regulatory Affairs or Quality role or equivalent time in a clinical laboratory, medical clinic or nursing experience.

Nice To Haves

• 1+ years’ experience in an IVD or medical device manufacturing environment.

Responsibilities

• Review medical complaints and potentially reportable events for the purpose of researching and gathering additional information needed to determine MDR and/or Vigilance reportability.
• Interact with cross-functional teams (e.g. Customer Service, Complaint Evaluations Group and Complaint Investigations Group) to gather appropriate information to determine whether a complaint requires an MDR and/or Vigilance report and/or submit an MDR/Vigilance follow-up report.
• Document filing decision rationale in the Complaint Handling System.
• File all medical events and reportable malfunctions within the required timeframe.
• Provide feedback and recommend solutions within the Quality team to promote accurate documentation of the complaint case.
• Assist in maintaining the Malfunction Reportability Assessment Matrix (MRAM), including updates to the Reportable Confirmed Malfunction List (RCML).
• Perform verification of MDRs/Vigilance reports, including support of data compiled for metrics, risk evaluations and various other activities.
• Assure compliance to the division's Medical Event and Quality System procedures.
• Interface with management and other functional areas to ensure that Potential Reportable Events (PREs) are obtained in a timely and consistent basis. The documentation of the work of the Medical Event Analyst is scrutinized by the Regulatory Agencies on a regular basis and compliance is measured by the accuracy and completeness of these documents. Failure to properly evaluate or report complaints could result in observations from regulatory agencies.
• Provide training and guidance to teammates and medical event reporting stakeholders.
• Demonstrate leadership in the continuous improvement of internal procedures and tools.
• Develop internal procedures and tools.
• Demonstrate commitment to the development, implementation and effectiveness of Abbott Quality Management System per ISO, FDA, and other regulatory agencies.
• Be responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

Benefits

• A fast-paced work environment where your safety is our priority
• Production areas that are clean, well-lit, and temperature-controlled
• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives, and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and a history of being actively involved in local communities

What This Job Offers

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