Senior Regulatory Affairs Professional

2 days ago

Galway, Galway, Ireland beBeeRegulatory Full time €100,000 - €130,000

We are seeking a highly skilled Senior Regulatory Affairs Professional to lead our regulatory affairs program in Galway, Ireland.

Job Description

The successful candidate will provide independent regulatory guidance to product development teams on International pre-marketing applications, and any related submissions to support optimal timelines for new/modified product launches and ongoing regulatory compliance.

  • Define data and information needed for regulatory approvals in conjunction with cross-functional product development teams.
  • Leverage a deep scientific and technical understanding of regulated products under scope of responsibility to provide strategic guidance and support for product development and life-cycle management of products.
  • Clearly define and prioritize decision criteria, consider the benefits and risks of each solution before making decisions.
Required Skills and Qualifications

To be successful in this role, you will require:

  • Strong experience in the medical device industry, with some experience in a position in regulatory affairs or related/equivalent field.
  • Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience.
  • Experience of inspection by an external agency, such as the FDA / BSI.
  • Ability to work well under deadlines and pressure.
  • Demonstrated track record in submission of licenses and authorizations for the maintenance of existing products, international registrations and dossiers, and execution of regulatory strategies that align with business deliverables.
Benefits

This is an excellent opportunity to join our team and take advantage of:

  • A challenging and rewarding career path.
  • A competitive salary and benefits package.
  • Opportunities for professional growth and development.
Others

We are committed to providing a supportive and inclusive work environment, where you can thrive and reach your full potential. If you are passionate about regulatory affairs and have a desire to make a real difference, we would love to hear from you.

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