Director, Regulatory Affairs (Medtech)

TL;DR

Director, Regulatory Affairs (Medtech): Leading global regulatory activities and GMP/ISO strategies to ensure compliance with medical device regulations with an accent on global market access and product lifecycle management. Focus on shaping regulatory strategy, guiding cross-functional teams, and ensuring adherence to FDA and MDR standards.

Location: Hybrid in Estenfeld, Germany (1-2 days remote)

Company

hirify.global, part of Thermo Fisher Scientific, develops innovative clinical trial technologies to help bring life-changing therapies to patients faster.

What you will do

• Lead global regulatory activities to ensure compliance with FDA 21 CFR 820, ISO 13485, and international medical device regulations.
• Define and implement regulatory strategies across the full product lifecycle, from development to post-market.
• Act as the Person Responsible for Regulatory Compliance (PRRC) under MDR requirements.
• Partner with Product Management, Logistics, and Engineering teams to ensure compliant product development.
• Guide and mentor hardware and software development engineers on regulatory expertise.
• Oversee regulatory submissions, including FDA 510(k) filings and international registrations.

Requirements

• Master’s degree in Engineering, Life Sciences, or a related technical field.
• 6+ years of experience in the medical device industry, with 4+ years specifically in Regulatory Affairs.
• 3+ years of proven leadership experience managing or guiding teams.
• Strong knowledge of FDA regulations, ISO standards, and MDR.
• Fluency in English and German.
• Must be based in or able to work hybrid in Estenfeld, Germany.

Culture & Benefits

• Competitive compensation package.
• Flexible working hours and working time accounts to support work-life balance.
• Hybrid work model allowing for 1-2 days of remote work.
• Professional development through internal and external training and certification programs.
• Comprehensive benefits focusing on security, flexibility, and well-being.