Staff Regulatory Affairs Specialist

Howmedica International SdeRL (Limerick, Ireland) 10 days ago

18 month fixed term contract. Usually based in either Limerick or Cork, currently fully work from home and open to candidates based in any part of Ireland.

Who we want:

Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

• Business-oriented evaluators. People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management and leadership teams

• Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations

• Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations

Data managers. People who enjoy compiling, organizing and consolidating large volumes of data and reports

What you will do:

As a Staff RA Specialist, you will work with cross functional teams providing Reg Affairs subject matter expertise for manufacturing transfers and manufacturing changes. You will drive and input into regulatory strategy and submissions.

This is a technical role and a good understanding of engineering principles would be advantageous.

What you need:

  • Strong technical writing skills
  • Good understanding of manufacturing processes
  • Experience with regulated change control processes
  • Experience compiling regulatory submissions

#LI-BC

Work From Home: RemoteTravel Percentage: 10%
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