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Regulatory Affairs Specialist II

  • Division: Engineering
  • Contact Email: emma.daly@collinsmcnicholas.ie
  • Job Ref: 23985

I am partnering with Abbott Rapid Diagnostics to hire a Regulatory Affairs Specialist II on an initial on 12 month contract to support an exciting new project : FULLY REMOTE .

The Role:

In this role you will prepare documentation for EU Technical Files and international product registrations.  

Responsibilities:

  • Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR).

  • Provides regulatory support for diagnostic product development and commercial diagnostic products.

  • Develops regulatory strategies for products in development and for modified products to achieve clearance/approval in the EU and internationally.

  • Provides regulatory support to regional regulatory teams to assist with submissions, license renewals, and license amendments.

  • Researches and communicates scientific and regulatory information in order to write submission documents. 

  • Compiles and publishes all material required for submissions, license renewals, and annual registrations.

  • Maintains approvals/licenses/authorisations for existing marketing authorisations.

  • Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations.

  • Develops internal procedures and tools.

  • Conducts informational or training sessions for stakeholders.

  • Organises and maintains hard copy and electronic department files.

  • Demonstrates commitment to the development, implementation and effectiveness of the Quality Management System per ISO, FDA, and other regulatory agencies.

  • Responsible for exhibiting professional behaviour with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

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Requirements:

  • Bachelor’s Degree in Biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience.

  • 4+ years’ experience in a Regulatory Affairs role.

  • Strong knowledge of IVDR and EU regulatory requirements is required.

Preferred:

  • 1+ years’ experience in an IVD or medical device manufacturing environment.

Competencies:

  • Good knowledge of EU and international regulations.

  • Demonstrated written and verbal communication skills.

  • Strong time management skills, with the ability to work on multiple projects simultaneously.

  • Ability to work independently as well as within a team.

  • Proficiency with Microsoft Office, including Word, Excel, PowerPoint and Visio

For a confidential discussion and more information on the role, please contact Emma Daly

emma.daly@collinsmcnicholas.ie

0861041202