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Regulatory Affairs Specialist - IVDR

abbott· 2129 Abbott Rapid DX
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📍 Ireland - GalwayFull time
Full time2129 Abbott Rapid DX

About this role

     

JOB DESCRIPTION:

Abbott in Ireland

Abbott has maintained a strong presence in Ireland since 1946 and celebrates its 80th anniversary in the country in 2026. The company supports the Irish healthcare sector with a broad portfolio spanning diagnostics, diabetes care, medical devices and nutritional products. Today, Abbott employs more than 6,200 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo.

About Abbott

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.

1 year contract

MAIN RESPONSIBILITIES

  • Supports the preparation of product registration submissions, progress reports, supplements, amendments, and periodic experience reports under guidance.
  • Assists in interactions with regulatory agencies to support timely approval of submissions.
  • Contributes to regulatory activities across the product lifecycle under supervision.
  • Participates in selected regulatory activities such as product plan implementation, regulatory documentation, and compliance support.
  • Supports the timely approval of medical devices and maintenance of regulatory approvals for marketed products.
  • Acts as a supporting regulatory contact for internal stakeholders including marketing and research teams.
  • Provides input to development and/or marketing teams on manufacturing changes, labelling updates, and applicable regulatory requirements with supervision.

QUALIFICATIONS AND COMPETENCIES

  • Minimum of a Bachelor’s Degree (BA/BS) from an accredited University

  • Minimum of  (1) year of experience in Regulatory Affairs role within a GMP / Biotech / Pharma / Medical Device/ IVD/ Regulated Industry.

  • Strong written and verbal communication skills

  • Ability to adapt quickly and effectively to shifting priorities.

  • Very strong attention to detail

  • Must be able to productively generate quality documentation to meet Program timelines

  • Strong skills in Microsoft Office, especially in Word, Excel, and PowerPoint

  • Good knowledge of Quality/Regulatory requirements in the IVD / Medical Device Industry including Medical Device and IVD Regulations, ISO13485, 21CFR820, ISO14971 and other standards and regulations applicable to IVD / Medical Devices.

  • Adaptability, Innovation, Initiative, Teamwork, Quality of Work, Commitment

Connect with us at www.abbott.com or https://www.ie.abbott/, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

ID Infectious Disease

        

LOCATION:

Ireland > Galway : Parkmore East Business Park

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Ie - 37.5Hst0 (Ireland)

     

TRAVEL:

No

     

MEDICAL SURVEILLANCE:

No

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable

     

     

     

Frequently Asked Questions

Is the salary disclosed for the Regulatory Affairs Specialist - IVDR position at abbott?
The salary for this Regulatory Affairs Specialist - IVDR role at abbott is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Regulatory Affairs Specialist - IVDR position at abbott located?
This Regulatory Affairs Specialist - IVDR role at abbott is based in Ireland - Galway. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Regulatory Affairs Specialist - IVDR role at abbott full-time or part-time?
This is listed as a Full time position. It is posted as a Regulatory Affairs Specialist - IVDR role in the 2129 Abbott Rapid DX department at abbott.
Which team or department does the Regulatory Affairs Specialist - IVDR at abbott belong to?
This Regulatory Affairs Specialist - IVDR position is part of the 2129 Abbott Rapid DX department at abbott. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Regulatory Affairs Specialist - IVDR position at abbott?
Click the "Apply Now" button on this page. You will be redirected to abbott's official application portal hosted on workday where you can submit your application directly.
When was the Regulatory Affairs Specialist - IVDR job at abbott posted?
This Regulatory Affairs Specialist - IVDR position at abbott was posted on Jul 27, 2026. Apply as soon as possible — early applications are often reviewed first.
Regulatory Affairs Specialist - IVDR
abbott
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