Sr Regulatory Affairs Specialist

Sr Regulatory Affairs Specialist

Clario

Remote, Europe

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.

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Multiple Countries      Clinical Research      Regulatory Affairs      Clario