Director, Regulatory Affairs (f/m/d)

DIRECTOR, REGULATORY AFFAIRS (F/M/D)

Join Clario, part of Thermo Fisher Scientific, as an Engineer, R&D Software Engineering (f/m/d) in Estenfeld and help develop innovative software solutions that support clinical research and accelerate the delivery of life-changing therapies to patients worldwide. In this role, you'll contribute to the design, development, testing, and continuous improvement of software products while working closely with cross-functional teams in an agile environment. Your work will directly impact the quality, reliability, and performance of technologies used across global clinical trials.

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, 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.

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Source: Statistisches Bundesamt (Destatis), table; dl-de/by-2-0; StarIn's calculation