Quality Professional for Post-Market Surveillance Reporting
About Us:
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.
Job Summary:
We are seeking a Quality Professional for post-market surveillance reporting to join our team. The successful candidate will be responsible for supporting the implementation and maintenance of post-market surveillance reporting, ensuring compliance with regulatory requirements. This role requires strong collaboration and communication skills, as well as the ability to analyze data and provide solutions that meet organizational objectives.
Responsibilities:
* 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.
* 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.
* Clients 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).
Requirements:
* Bachelor's degree in Life Science, Engineering, or closely related discipline is required OR relevant combination of education or experience.
* Demonstrated knowledge and/or understanding of Health care industry.
* Prior experience in Has a history of completing successful projects and driving positive compliance outcomes.
* At least 3 year's work experience in a related field experience; less experience may be appropriate with advance degree.
What We Offer:
Abbott is an equal opportunity employer, welcoming and encouraging diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities.