1.POSITION SUMMARY

Abbott Rapid Diagnostics (ARDx) is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

• This Quality Professional position is focused on supporting the implementation & maintenance of ADRx’s post-market surveillance reporting to meet the requirements for the In-Vitro Diagnostics Regulation (IVDR) into ARDx’s Quality System. Additionally, the Quality Professional for post-market surveillance reporting leads activities assigned to them, collating needed inputs for reporting, working collaboratively with a broad cross-functional team.

12-month FTC

3.BASIC QUALIFICATIONS – EDUCATION / EXPERIENCE / SKILLS

• Bachelor’s degree in Life Science, Engineering, or closely related discipline is required OR relevant combination of education or experience.

4. PREFERRED QUALIFICATIONS

• Demonstrated knowledge and/or understanding of Health care industry.
• Prior experience in Has a history of completing successful projects and driving positive compliance outcomes.

• Carries out duties in compliance with established business policies and procedures.
• Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.
• 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.
• Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.
• Perform other duties and projects as assigned.
• Supports the implementation and maintenance of the effectiveness of the Quality System with respect to collation of data and generation of reports required to support post market surveillance reporting submissions, as assigned.
• Works collaboratively with a global cross-functional team to revise existing or establish new quality system requirements/processes, procedures and report templates compliant with the new regulation with respect to post-market surveillance reporting.
• Uses critical thinking to provide solutions that are compliant, innovative and consistent with organizational objectives.
• Coordinates and leads the assigned schedule associated with the accrual, assembly of post-market surveillance inputs ensuring accurate and timely submission. Supports the processes for acquiring, managing, analyzing, interpreting and reporting Post Market Surveillance data necessary to support PMS Reports such as Periodic Safety Update Report (PSUR), Post Market Performance Follow-Up (PMPF), Post Market Clinical Follow-up (PMCF), Clinical Evaluation Report (CER) and related reports along with supporting the maintenance of appropriate Design History File (DHF) documents such as Risk Management Files (RMF).
• Partners with Vigilance, Regulatory Affairs, Clinical Affairs, product, instrument and software teams, Field Assurance, Marketing and manufacturing facilities to proactively plan for and complete PMS reports, ensuring needed data is gathered accordingly.
• Elevates and articulates concerns to management in a timely manner, proposing solutions and leading change as needed.
• As a post-market surveillance reporting subject matter experts, supports audits and additional information request inquiries relating to post-market surveillance reporting.