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Associate Regulatory Affairs Specialist

Job Title: Associate Regulatory Affairs Specialist
Contract Type: Permanent
Location: Galway
REF: 90859
Job Published: 8 months ago

Job Description

Contact: Bimi Felix
Telephone: 086 8395533
Associate Regulatory Affairs Specialist

Our client, a medical device company in Galway are currently looking to recruit an Associate Regulatory Affairs Specialist for their site.

Our Offer
  • You will contribute to the activities of our Regulatory Affairs group and demonstrate flexibility as priorities change.
  • You will be responsible for supporting department goals and continuous improvement initiatives.
  • You will provide support for the review and approval of Change Requests and taking action on International Requests.
  • You will support Global Product Registrations/Submissions.
  • You will liaise with project teams as necessary to obtain information in support of these registrations.
  • You may be required to communicate with external regulatory agencies (FDA, notified bodies etc.) during the registration process.
  • You may be required to interpret new Medical Device Regulations and develop internal procedures to ensure continuous compliance with all regulatory requirements.
Your Profile
  • We are looking for a qualified person to Level 8 Bachelor’s Degree/Masters or equivalent in Science or related discipline.
  • Regulatory experience is desirable, however, candidates with a minimum of 0 - 1 year’s relevant experience will also be considered.
  • You are a dynamic team player and can work effectively and pro-actively on activities both individually and in teams.
  • You are experienced with Microsoft Word, Excel and PowerPoint, and knowledge of Adobe Acrobat and Data Management Systems are desirable.
  • You are skilled in thinking critically and making sound decisions.
  • You collaborate with others and create alignment with team members.
  • You set high standards and drive accountability in the execution of your responsibilities and you model ethical behaviour.
  • You are a good communicator and fluent in English, both in writing and speaking with strong organizational skills.

For further information on this Associate Regulatory Affairs Specialist role in Galway please contact Bimi Felix on 086 8395533 /
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