Job description:

Join Clario, part of Thermo Fisher Scientific, as Director of Regulatory Affairs (f/m/d) and play a key role in ensuring that innovative technologies for clinical trials meet global regulatory requirements and that life-changing therapies reach patients faster. In this role, you will shape the regulatory strategy, work closely with cross-functional teams, and ensure compliance in international markets. This will make a significant contribution to patient safety and product quality.

What we offer:

- Attractive and competitive compensation.

- Flexible working hours and time accounts for a better work-life balance.

- Hybrid work model with the option to work remotely 1 to 2 days per week.

- Support for your professional and personal development through internal and external training and certification programs.

- Attractive benefits in the areas of safety, flexibility, support, and well-being.

- Diverse employee programs and events.

Your responsibilities

: - You will lead global regulatory activities and ensure compliance with FDA 21 CFR 820, ISO 13485, and international regulations for medical devices and other regulated products.

- You will develop and implement regulatory strategies across the entire product lifecycle – from development to the post-market phase.

- You will work closely with the product management, logistics, and engineering teams to ensure regulatory-compliant product development and global market access.

- You will establish and optimize global processes for trade compliance, import and export requirements, and regulatory requirements within the supply chain.

- You will lead and coach a team of hardware and software developers and contribute your regulatory expertise to projects such as respiratory, imaging, and cardiac safety solutions.

- You will assess the regulatory impact of changes to design, materials, labeling, software, and suppliers.

- You support regulatory approval processes, including FDA 510(k) submissions and international product registrations.

- You review and approve product labeling, technical documentation, and marketing materials to ensure regulatory compliance.

- You will participate in internal, external, and supplier audits and support Corrective and Preventive Action (CAPA) initiatives.

- You will assume the role of Person Responsible for Regulatory Compliance (PRRC) in accordance with the requirements of the Medical Device Regulation (MDR).

- You will be responsible for developing and maintaining SOPs and work instructions in line with global standards.

- You will support post-market surveillance, vigilance reporting, and continuous improvement activities.

What you bring to the table:

- A completed Master's degree in Engineering, Life Sciences, or a comparable technical field.

- At least 6 years of professional experience in the medical device industry.

- At least 4 years of experience in regulatory affairs for medical devices or pharmaceutical products.

- At least 3 years of proven leadership experience in managing or providing technical guidance to teams.

- In-depth knowledge of FDA regulations, ISO standards, and global medical device requirements, including 510(k) filings and the MDR.

- Experience in collaborating with regulatory authorities and supporting audits and inspections.

- Knowledge of clinical trial environments and Good Clinical Practice (GCP) is advantageous.

- Strong analytical, organizational, and communication skills.

- Excellent written and spoken German and English.

- A structured and detail-oriented work style, as well as strong problem-solving skills to successfully navigate complex regulatory challenges.

About Clario

At Clario, part of Thermo Fisher Scientific, we share a common purpose: to transform lives by building better evidence. This mission unites and inspires us every day. Whether you're advancing clinical research, developing innovative technologies, or supporting our global teams, your work contributes to bringing life-changing therapies to patients faster. Together, we are making a significant contribution to the future of healthcare.

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