Regulatory Affairs Specialist

TKey Responsibilities

• Manage all regulatory and QA activities, including FDA clearance and CE/M MDR, including technical dossier preparation and leading submissions.
• Establish and lead the regulatory plan for all the clinical applications products.
• Implement and maintain the company’s quality system regulations
• Manage the preparation, supervision and follow-up of usability studies
• Manage the Risk Management & PMS activities
• Lead, manage and coordinate all compliance processes in accordance with ISO 13485 standards, UL and other certificates, with the relevant safety testing.
• Manage the regulatory budget.

Requirements:

• BA/BSc Biomedical engineering, biotechnology, medical sciences, Biology or related fields.
• At least 3 years of experience in RA for a medical device company, preferably for class II or class III
• Strong background in a regulation consultancy is an advantage
• Well familiar with the FDA regulatory submissions; Class III / Class II Denovo is an advantage
• Experienced with CE MDR, AMAR regulatory is an advantage
• Hands-on, a self-starter, gets things done smoothly
• A motivated team coach has the ability to lead people toward desired outcomes
• Team player
• creative thinker with a flexible mindset that enables you to have a good conversation with anyone