Regulatory Affairs Specialist (Medtech)

TL;DR

Regulatory Affairs Specialist (Medtech): Leading regulatory compliance activities for medical devices with an accent on EU MDR and CE marking. Focus on managing technical documentation for Class IIa/IIb devices and coordinating with Notified Bodies to ensure market access.

Company

hirify.global is an independent international consulting and technology firm providing strategic solutions for over 1,000 clients globally across information systems, telecommunications, life sciences, and engineering.

What you will do

• Lead Regulatory Affairs activities for medical devices to ensure full compliance with EU MDR (Regulation (EU) 2017/745).
• Act as an expert in medical device classification, specifically for Class IIa and IIb devices.
• Coordinate the preparation, review, and maintenance of technical documentation according to Annexes II and III of the EU MDR.
• Manage CE Marking processes and maintain direct interaction with Notified Bodies and health authorities.
• Analyze regulatory changes to assess impact on product portfolios and define strategic regulatory roadmaps.
• Advise Quality, Clinical, R&D, and Supply Chain teams on regulatory matters throughout the product lifecycle.

Requirements

• 5+ years of experience in Regulatory Affairs specifically for medical devices.
• Proven expertise in EU MDR regulations and Class IIa/IIb device classification.
• Experience working directly with Notified Bodies and health authorities.
• Academic background in Pharmaceutical Chemistry, Biomedical Engineering, Pharmacy, Health Sciences, or a related field.
• Advanced or fluent English proficiency (written and spoken).

Nice to have

• Advanced or fluent proficiency in French.

Culture & Benefits

• Opportunity to work in an international, dynamic, and fast-growing consulting environment.
• Role as a strategic partner and technical expert for diverse clients across multiple industries.
• Commitment to diversity and an inclusive work environment with equal opportunities for all.

Hiring process

• Initial virtual or telephone screening to discuss motivations and fit.
• Average of three interviews with a direct manager and future team members.
• Potential case study, role-play, or technical assessment depending on the specific role requirements.