Director, Regulatory Affairs (Medical Devices)

TL;DR

Director, Regulatory Affairs (Medical Devices): Leading global regulatory activities to ensure compliance with FDA and ISO standards for clinical trial technologies with an accent on regulatory strategy and global market access. Focus on managing product lifecycles, guiding cross-functional teams, and overseeing FDA 510(k) filings and MDR requirements.

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

Company

hirify.global, part of Thermo Fisher Scientific, focuses on transforming lives by unlocking better evidence in clinical science and building innovative technology.

What you will do

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

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 is required.
• Must be based in or able to work in Estenfeld, Germany.

Nice to have

• Understanding of clinical trial environments and Good Clinical Practice (GCP).

Culture & Benefits

• Competitive compensation and flexible working hours with working time accounts.
• Hybrid work model allowing for 1-2 days of remote work.
• Access to internal and external training and certification programs for professional development.
• Comprehensive benefits focusing on security, flexibility, and well-being.
• Engaging employee programs within a global scientific environment.