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Senior Regulatory Affairs Specialist

Job Title: Senior Regulatory Affairs Specialist
Contract Type: Permanent
Location: Galway
Industry:
REF: 88059
Job Published: 23 days ago

Job Description

Contact: Bimi Felix
Email: bimi@hero.ie
Telephone: 091730022

Senior Regulatory Affairs Specialist
Our client, a world leading medical device manufacturer requires a Senior RA Specialist to join their team in Galway. This role requires setting high standards and driving accountability with excellent benefits and career progression opportunity.

Key Responsibilities:
  • Responsible for supporting department goals.
  • Responsible for the review and approval of Change Requests and taking action on International Requests.
  • Lead the planning and execution of Global Product Registrations/Submissions.
  • Participate as part of a project team to obtain information in support of these registrations and communicate with multiple contacts in international regions.
  • Communicate with external regulatory agencies (FDA, notified bodies etc.) during the registration process. You will support new product development as an extended RA core team member.
  • May be required to interpret new Medical Device Regulations and develop internal procedures to ensure continuous compliance with all regulatory requirements.

Education, Experience and Skills
  • Level 8 Bachelor's Degree/Masters or equivalent in Science or a relevant discipline.
  • 5 years relevant medical device industry experience will also be considered.
  • Work effectively and pro-actively on activities both individually and in teams.
  • Experienced with Microsoft Word, Excel and Powerpoint, and knowledge of Adobe Acrobat and Data Management Systems are preferred.
  • Collaborate with others, seeking different perspectives and ideas to foster an inclusive work environment.
  • Practice a culture of integrity, ethics and compliance with laws and policies.
  • Good communicator and fluent in English.
For further information on this Senior RA Specialist in Galway please contact Bimi Felix on 091 730022/ bimi@hero.ie
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