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.
- 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.
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