MedTech Officer

Updated: April 21, 2024 02:57 AM GMT

ASPHALION

Pamplona

Do you want to join in our team and work with our Medical Device unit? Do you want to apply your knowledge in RA & medical device?

We are waiting for you!

Main Responsabilities:
• Work with direct reports to develop successful global regulatory strategies to ensure timely device approvals: roadmaps, viability analysis, clinical evaluation, risk management
• Guide clients in decisions concerning medical device product development and promotion
• Collect and coordinate information and prepare regulatory documentation for submission to different regions worldwide (EU, USA, etc.): technical file preparation & review (CE marking), FDA clearance (510(k)) and premarket approval (PMA)
• Communication with notified bodies
• Business development and marketing activities
• Establishing processes and working instruction

Requirements:
• Degree in biological/pharmaceutical sciences or biomedical engineering.
• 1-2 years’ experience in RA & Technical Documentation - Medical Devices
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