About this role
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.
Ansprechpartner
Nathalie Fischer
Jetzt bewerben [https://clarioclinical.wd1.myworkdayjobs.com/en-US/clarioclinical_careers/details/Director--Regulatory-Affairs--f-m-d-_R17870]