
Regulatory Affairs Specialist
4 days ago
XVIVO is a global medical technology company dedicated to extending the life of organs. We are in a rapid growth phase, expanding geographically and developing new products and supporting processes.
Key Responsibilities:- Manage vigilance/MDR reporting for markets where XVIVO has a presence.
- Lead regulatory affairs for projects developing new products.
- Execute project regulatory planning, ensuring compliance with global medical device regulations.
- Maintain product registrations by ensuring compliance with applicable regulatory requirements.
- University degree in a relevant field such as Science or Engineering.
- Professional experience in Regulatory Affairs, with demonstrated knowledge/experience in quality management systems and medical device regulations.
- Deep understanding of regulatory requirements for EU and USA markets.
- Proven track record of handling product registrations and submissions.
- Excellent written and spoken English skills.
- Award-winning company culture.
- Opportunities for career growth and development.
- Collaborative and dynamic work environment.
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