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.
Apply Now
Don't forget to mention EuroPharmaJobs when applying.