Our client, a Medtech company based in Galway, now seeks an experienced Regulatory Affairs Submissions Specialist to work in a fast-paced dynamic global team on a permanent basis. This leadership role offers opportunity for global technical regulatory affairs work (e.g., new product development projects, sustaining projects, MDR compliance programs), in conjunction with team leadership and people development.
The successful candidate will lead planning, managing, and implementing regulatory submissions to the US FDA, EU notified bodies, as well as supporting world-wide product registrations for US, EU and International approvals for medical devices and/or drug-device combination products.
The hire will directly engage with Health Authorities (e.g.: Pre-submission meetings, responses to regulatory information submission requests).
The ideal candidate will have proven knowledge of EU and US medicinal product, including drug led combination products, regulatory submission requirements (e.g., MAA, NDA, ANDA).
Requirements for Senior Regulatory Affairs Submissions Specialist:
Bachelor’s degree qualification in Science / Engineering discipline. Advanced qualifications are desirable.
5+ years Regulatory Affairs Experience supporting medical devices and/or drug-device combination products.
Previous experience within Regulatory Affairs, regulating Class III combination devices, with knowledge of US FDA regulations on medical device and combination products.
Advanced knowledge of the EU MDR 2017/745 and associated guidance documents (e.g.: MDCG Guidance Documents) and QMS requirements (i.e., ISO 13485)
Experience in directly engaging with Health Authorities.
Excellent verbal and technical writing skills.
For further details, please contact Larry on +353 1-2302400 / email@example.com
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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