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Quality Professional – Post Market Surveillance - IVDR

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Abbott Laboratories

25d ago

  • Job
    Full-time
    Mid Level
  • Research & Development
    Healthcare
  • Galway

AI generated summary

  • You need a Bachelor’s in Life Science or related field, knowledge of healthcare, 3+ years in a related role, and a track record of successful projects and compliance outcomes.
  • You will ensure compliance with quality processes, manage post-market surveillance data, collaborate with cross-functional teams, and support audits and report submissions.

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.

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.
  • 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.

FAQs

What is the role of a Quality Professional in Post Market Surveillance at Abbott Rapid Diagnostics?

The Quality Professional is responsible for supporting the implementation and maintenance of post-market surveillance reporting to comply with the In-Vitro Diagnostics Regulation (IVDR). They lead activities related to data collection, report generation, and collaboration with cross-functional teams.

What qualifications are required for this position?

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

How many years of experience is preferred for this role?

At least 3 years of work experience in a related field is preferred; however, less experience may be acceptable with an advanced degree.

Is experience in the healthcare industry necessary?

Demonstrated knowledge and/or understanding of the healthcare industry is preferred but not explicitly required.

What specific duties are included in the role?

The role includes collating data for post-market surveillance, generating required reports, ensuring compliance with regulations, collaborating with various teams, and supporting audits related to post-market surveillance reporting.

What type of reports will the Quality Professional be involved in?

The Quality Professional will be involved in preparing reports such as Periodic Safety Update Report (PSUR), Post Market Performance Follow-Up (PMPF), Post Market Clinical Follow-up (PMCF), and Clinical Evaluation Report (CER), among others.

What collaboration is expected from the Quality Professional?

The Quality Professional will work collaboratively with Vigilance, Regulatory Affairs, Clinical Affairs, product teams, Field Assurance, Marketing, and manufacturing facilities to gather necessary data for PMS reports.

Is this position a permanent or temporary role?

This position is a 12-month fixed-term contract (FTC).

What competencies are valued for this position?

Candidates should demonstrate effective critical thinking, project management, and the ability to drive positive compliance outcomes within related fields.

Does Abbott provide accommodations for individuals with disabilities?

Yes, Abbott provides reasonable accommodations to qualified individuals with disabilities.

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Abbott Laboratories

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

At Abbott, we’re dedicated to helping people live more fully, in everything we do. We’re creating the future of healthcare through life-changing technologies that make you healthier and stronger, quickly identify when you have a medical need, and treat conditions to help you get back to doing what you love. With headquarters in north suburban Chicago, Abbott serves people in more than 160 countries with leading medical devices, diagnostics, nutrition products and branded generic medicines. More than 115,000 of us are helping millions of people to live better and healthier, every day around the world. Our employees do work that matters as part of a global community that supports them with career development opportunities and locally competitive benefits. Mission: We help people live better and healthier with our life-changing technologies. We're revolutionizing health with the most personal technologies, empowering people with the data and knowledge they need to help them live longer and better.