Director of Regulatory Affairs

Clario; Würzburg; Hybrid; EUR 120,000 - 180,000; Full time

Benefits offered by this job

Hybrid work model

Flexible working hours

Internal and external training

Well-being programs

Competitive compensation

Job summary

Clario, part of Thermo Fisher Scientific, is seeking a Director, Regulatory Affairs (f/m/d) to shape regulatory strategy across global markets and ensure compliance of medical devices and pharma products. You will guide cross-functional teams and ensure patient safety and product quality through robust regulatory oversight.

You will lead submissions (FDA 510(k) and international), mentor engineers, and establish global processes for trade, import/export, and post‑market surveillance.

Qualifications

• Master’s degree in Engineering, Life Sciences, or related field.
• 6+ years in the medical device industry.
• 4+ years in Regulatory Affairs within medical devices or pharma.
• 3+ years of leadership experience.
• Strong knowledge of FDA regulations, ISO standards and MDR.
• Fluency in English and German.

Responsibilities

• Lead global regulatory activities to ensure compliance with FDA 21 CFR 820, ISO 13485 and international regulations.
• Define and implement regulatory strategies across the full product lifecycle.
• Partner with Product Management, Logistics, and Engineering to ensure compliant development and market access.
• Establish and optimize global processes for trade compliance, import/export, and supply chain regulatory requirements.
• Mentor a team of hardware and software engineers, providing regulatory guidance.
• Assess regulatory impact of design changes and supplier changes.
• Support regulatory submissions, including FDA 510(k) filings and international registrations.
• Review labeling, technical docs, and marketing materials for regulatory alignment.
• Participate in audits and drive corrective/preventive actions.
• Act as PRRC under MDR requirements and oversee SOPs/work instructions.
• Support post-market surveillance and continuous improvement.

Skills

Regulatory leadership

Regulatory submissions

Cross-functional leadership

FDA regulations

Education

Master’s degree in Engineering, Life Sciences, or related field

Job description

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 the work‑life balance.
• Hybrid work model, allowing for 1-2 days of remote work.
• Support your professional development through internal and external training and certification programs.
• Attractive benefits (security, flexibility, support and well‑being).
• Engaging employee programs.

What you'll be doing

• 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

What we look for

• 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

At Clario, part of Thermo Fisher Scientific, our purpose is to transform lives by unlocking better evidence. It’s a cause that unites and inspires us. It’s why we come to work—and how we empower our people to make a positive impact every day. Whether you’re advancing clinical science, building innovative technology, or supporting our global teams, your work helps bring life‑changing therapies to patients faster.