eResearchTechnology GmbH

Overview

Join Clario, part of Thermo Fisher Scientific, as Director, Regulatory Affairs (f/m/d) and play a critical role in ensuring that innovative clinical trial technologies meet global regulatory standards – helping bring life‑changing therapies to patients faster. In this role, you will shape regulatory strategy, guide cross‑functional teams, and ensure compliance across global markets, making a meaningful impact on patient safety and product quality.

What We Offer

• Competitive compensation
• Flexible working hours and working time accounts to support work‑life balance
• Hybrid work model, allowing 1-2 days of remote work per week
• Support for professional development through internal and external training and certification programs
• Attractive benefits – security, flexibility, support, and well‑being
• Engaging employee programs

Responsibilities

• Lead global regulatory activities to ensure compliance with FDA 21 CFR 820, ISO 13485, and international medical and non‑medical device regulations
• Define and implement regulatory strategies across the full product lifecycle, from development to post‑market
• Partner with Product Management, Logistics, and Engineering teams to ensure compliant product development and global market access
• Establish and optimize global processes for trade compliance, import/export, and supply‑chain regulatory requirements
• Guide and mentor a team of hardware and software development engineers, providing regulatory expertise across projects such as respiratory, imaging, and cardiac safety solutions
• Assess regulatory impact of changes to design, materials, labeling, software, and suppliers
• Support regulatory submissions, including FDA 510(k) filings and international product registrations
• Review and approve product labeling, technical documentation, and marketing materials to ensure regulatory alignment
• Participate in internal, external, and vendor audits and contribute to corrective and preventive action initiatives
• Act as Person Responsible for Regulatory Compliance (PRRC) under MDR requirements
• Oversee the development and maintenance of SOPs and work instructions aligned with global standards
• Support post‑market surveillance, vigilance reporting, and continuous improvement activities

Qualifications & Experience

• Master’s degree in Engineering, Life Sciences, or a related technical field
• 6+ years of experience in the medical device industry
• 4+ years of experience in Regulatory Affairs within medical devices or pharmaceutical products
• 3+ years of proven leadership experience managing or guiding teams
• Strong knowledge of FDA regulations, ISO standards, and global medical device requirements (including 510(k) submissions and MDR)
• Experience interacting with regulatory authorities and supporting audits and inspections
• Understanding of clinical trial environments and GCP is highly desirable
• Excellent analytical, organizational, and communication skills
• Fluency in English and German
• Detail‑oriented with strong problem‑solving capabilities and the ability to manage complex regulatory challenges