Senior Regulatory Affairs Specialist

Location: Galway, Republic of Ireland Salary:
Sector: Regulatory Affairs (RA) Type: Permanent

Why should I apply for Senior Regulatory Affairs Specialist?

My client are one of Ireland's most reputable medical device company. They are looking for a Senior Regulatory Affairs Specialist to join them on a permanent basis. Located close to Galway City Centre, my client's site is the largest manufacturing facility in their global plant network.

As Senior RA Specialist, you will be responsible for Regulatory Affairs support of the product development process, submissions and regulatory compliance.

This is an excellent opportunity for someone currently working in Regulatory Affairs within the medical device, or someone with excellent knowledge FDA regulations, ISO 13485 and the Medical Device Directive in a quality/similar role.

What will I be doing as Senior Regulatory Affairs Specialist?

  • You will be an effective team leader, fully motivated to achieve and demonstrate best practices in line with the goals of the regulatory department.
  • You will interface with manufacturing, engineering, R&D and quality representatives to provide consultation on the impact of proposed changes to product, processes and the quality system.
  • You will act as a team member in product development programmes and demonstrate a good understanding of the PDP process.
  • You will maintain and enhance cross-functional team relationships.
  • You will review applicable Corporate SOP's for effect on local regulatory processes and systems.
  • You will prepare and maintain Technical Files, Design Dossiers and FDA submissions including IDEs, 510k's and PMAs.
  • You will review and approve documentation related to product release.
  • You will provide input, review and approve artwork for labelling and DFU's
  • You will participate in Regulatory body audits, such as FDA, Notified Bodies, Competent Authorities and other global regulatory agencies.
  • You will liaise and provide support to international regulatory colleagues.
  • You will demonstrate and actively promote highest level of professional regulatory discipline.
  • You will liaise with both middle and senior management on any regulatory issues relating to their area.

What do I need to apply for Senior Regulatory Affairs Specialist?

  • Bachelor's Degree in Engineering, Science or Quality Assurance
  • Experience in FDA regulations, ISO 13485 and the Medical Device Directive is required
  • Good administrative/organisational ability with attention to detail is required
  • Technical writing qualification desirable
  • Stamp 4 Visa / EU passport for consideration

Interested in this opportunity in Galway? Want to discuss further? Apply now with a recent copy of your CV and I can follow up with you.

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