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Quality Professional - Post Market Surveillance - IVDR

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Abbott Laboratories

5d ago

  • Job
    Full-time
    Mid Level
  • Healthcare
  • Galway

AI generated summary

  • You need a Bachelor's in Life Science or Engineering, 3+ years of relevant experience, and knowledge of the healthcare industry to succeed in this role.
  • You will ensure compliance with quality processes, manage post-market surveillance data, collaborate on reports, and support audits while maintaining effective communication with cross-functional teams.

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 job title for this position?

The job title is Quality Professional - Post Market Surveillance - IVDR.

What company is hiring for this position?

Abbott is hiring for this position.

What will be the primary focus of this Quality Professional role?

The primary focus will be supporting the implementation and maintenance of post-market surveillance reporting in accordance with the In-Vitro Diagnostics Regulation (IVDR).

Is this position permanent or temporary?

This is a 12-month Fixed Term Contract position.

Where is the Abbott Galway site located?

The Abbott Galway site serves as the international hub for Abbott's Rapid Diagnostics business.

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 are preferred for this role?

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

What kind of projects will the Quality Professional be involved in?

The Quality Professional will be responsible for collating data, generating reports required for post-market surveillance, and collaborating with cross-functional teams on quality system requirements and processes.

Will this role involve collaboration with other departments?

Yes, the role will involve working collaboratively with various departments including Vigilance, Regulatory Affairs, Clinical Affairs, and more.

What types of reports will this position be responsible for?

The position will be responsible for 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.

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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.