Principal Regulatory Affairs Lead
Principal Regulatory Affairs Lead, Class IIB & III, rapidly expanding Medical Device company, Galway City
My partner is an international medical device company who has just recently launched their innovative medical device in the United States to great success. They are seeking to follow up the fantastic launch with more products in the new year and planned design changes. On that basis, we need a Senior Regulatory Affairs Professional to join the team to primarily lead submissions of devices under development, CE Mark maintenance and substantial change submissions. The focus is on pre-market activities but as the team is relatively small, someone interested in keeping busy and having a broad range of responsibilities will thrive here.
This isn't a monster multinational where you have lots of redtape and slow cross departmental communication. Communication will be fast - enabling you to do your job with as minimal bureaucratic nonsense as possible. A competitive salary package is on offer here paired with working flexibility. As the company is set to explode in 2021, it's a really great time to join and forge your path within the company with strong professional development opportunities along-side the company growth.
What will you do?
- Lead compilation of international regulatory submissions for products under development, as required
- Manage regulatory submission timelines, identify risks and appropriate mitigations
- Review the data intended for submission in international regulatory applications. Identify gaps and make recommendations.
- Define and capture the regulatory strategy for the development project(s)
- Co-ordinate and support regulatory reviews and meetings with FDA, PMDA and NMPA
What do you need?
- Minimum of 6 years relevant RA experience for the Medical Devices industry (class IIB and III preferred)
- Technical competency in the following:
- MDD 93/42/EEC
- MDR 2017/745
- FDA QSRs
- Strong communication and organizational skills enabling you to present reports to relevant stakeholders
For more information please send a recent copy of your CV on a MS Word document to Blaine McKeever. Successful candidates will be contacted immediately, and presented with current vacancies.
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