Principal Regulatory Affairs Specialist (Medical Events)

Abbott; Lake Forest (IL); On-site; USD 78,000 - 156,000; Full time

Job summary

Abbott in Lake Forest, IL seeks a Principal Regulatory Affairs Specialist (Medical Events) to oversee timely review, documentation, and filing of Medical Device Reports including international vigilance for the division's products.

You will ensure compliance with MDR regulations and support cross-functional teams in accurate reporting, documentation, and process improvements within Abbott's Quality Management System.

Qualifications

• BS/BA in science or related field; 4+ years in Regulatory Affairs or Quality role or equivalent lab/nursing experience.
• Experience with regulatory history, guidelines, policies, standards, practices and precedents is preferred.

Responsibilities

• Review medical events to determine MDR/Vigilance reportability.
• Coordinate with Customer Service, Complaint Evaluations Group and Complaint Investigations Group to gather information.
• Document filing rationale in the Complaint Handling System.
• File medical events and reportable malfunctions within required timeframes.
• Provide feedback to promote accurate documentation in the Quality team.
• Maintain MRAM and RCML lists and update as needed.
• Verify MDRs/Vigilance reports and support data for metrics and risk evaluations.
• Ensure compliance with Medical Event and Quality System procedures.
• Interface with management to obtain PREs timely and consistently.
• Ensure documentation is accurate for regulatory review.

Skills

Regulatory knowledge

Documentation

Cross-functional collaboration

Attention to detail

Education

Science degree (Chemistry, Microbiology, Biology, Biochemistry) or Nursing/Engineering

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

Working at Abbott

Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life.

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

The Opportunity This position works out of our Lake Forest, IL location in the Infectious Disease, Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

The Principal Regulatory Affairs Specialist (Medical Events) will be responsible for timely review, documentation and filing of Medical Device Reports, including international vigilance reports for the division's products. Accountable for meeting the compliance requirements for Medical Device Reporting regulations including (803). The Principal Regulatory Affairs Specialist (Medical Events) but is not limited to the efficient and timely review, documentation and filing of potentially reportable events.

What You’ll Work On

• 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.
• Filing of 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.
• 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.

Required Qualifications

• 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 Regulatory Affairs or Quality role or equivalent time in a clinical laboratory, medical clinic, or nursing experience.

Preferred Qualifications

• 1+ years’ experience in an IVD or medical device manufacturing environment.
• 2 -3 years experience in a regulated industry (e.g., medical products, nutritionals).
• Regulatory areas are preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related areas.
• Experience with Regulatory history, guidelines, policies, standards, practices, requirements and precedents.

Significant Work Activities

• Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day).
• Keyboard use (greater or equal to 50% of the workday).

Job Family

Regulatory Operations

DIVISION

ID Infectious Disease

LOCATION

United States > Lake Forest : J55

ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: Not Applicable

Pay

The base pay for this position is $78,000.00 – $156,000.00 In specific locations, the pay range may vary from the range posted.

EEO

Abbott is an Equal Opportunity Employer, committed to employee diversity.

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Company Culture

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

Connect with us at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.