We are looking for you as Senior Regulatory Affairs Specialist (f/m/d) to join our dynamic, international and innovative Clario team!

If you are interested in topics like EU AI Act and SaMD, we would be happy to get to know you better!

What we offer:

• Flexible working hours and working time accounts to support the work-life balance

• Support your professional development through internal and external training and certification programs

• Working from home or in our modern office building with an on-site canteen - the choice is yours!

• Competitive salary, yearly merit process and bonus

What you'll be doing:

• Providing expert regulatory support for exciting projects, ensuring compliance with international standards like 21 CFR 820, EU MDR, EU RED, FCC, MDSAP, ISO 13485, and ISO 9001.

• Ensuring our innovative medical and non-medical devices meet essential requirements across various global markets, including the EU, US, Canada, Japan, Australia, and China. ·

• Crafting and executing strategic regulatory plans for our products, assessing the impact of changes in design, materials, labeling, software, and suppliers.

• Preparing and submitting country registrations in line with our product road map.

• Staying ahead of regulatory changes and analyzing their impact on our products, processes, and services, keeping our company and clients informed and compliant.

• Guiding and training our teams to effectively translate regulatory requirements into practical specifications and improvements.

• Reviewing and conducting gap analyses on technical and design control documentation, ensuring alignment with current standards and regulations.

• Contributing to quality tasks within development projects, supporting Post Market Surveillance and Post Market Clinical Follow-up activities.

• Leading corrective and preventive actions for both medical and non-medical devices.

• Continuously improving regulatory and quality compliance SOPs and work instructions to maintain top-tier standards.

What we look for:

• A Bachelor's degree in Regulatory Affairs, Life Sciences, Medical, Technical, or Electrical Engineering, or equivalent. ·

• 5+ years' experience working with regulated products, especially medical devices.

• Proven expertise in regulatory affairs for medical devices and/or clinical trials.

• Experience with computerized systems used in clinical trials, including medical and non-medical device systems.

• A strong background in Risk Management activities.

• Excellent troubleshooting and communication skills.

• Comprehensive knowledge of international regulatory requirements and product certification processes (e.g., US, EU, China, Japan, Canada).

• Proficiency with 21 CFR Part 820, EU MDR, ISO 13485, ISO 9001, and 21 CFR Part 11.

• Fluency in English; proficiency in a second language is a plus.

At Clario, we put people first, always. We are united and driven by patients, committed to making a difference, and we are always looking for the best talent to help us transform lives. We value the contribution each of our people brings. It’s only through our people that we can continue to innovate technology that will shape the future of clinical trials.

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