
Medical Device Regulatory Expert
3 days ago
Do you want to be a part of an innovative healthcare team? We have a fantastic opportunity for a Regulatory Affairs Associate.
About the role:
- We are looking for someone with a strong understanding of regulatory frameworks and quality standards, especially in the medical device or IVD sector.
- Your primary responsibility will be to support on-market activities, develop regulatory strategies, prepare and lodge submissions, and review documents for scientific integrity.
- You will also advise global teams on local compliance needs, partner with marketing to review promotional content, offer mentorship, and maintain knowledge of relevant laws and regulations.
The ideal candidate will have:
- A degree in science, biomedical studies, or a related field.
- At least 2-3 years of experience in regulatory affairs within the medical device or IVD sector.
- Familiarity with ISO 13485 and other relevant quality standards.
- Excellent communication skills and attention to detail.
- A mindset geared toward innovation and continuous improvement.
Benefits include career development opportunities, access to international networks, and a collaborative work environment. If you are proactive, results-driven, and passionate about regulatory affairs, we encourage you to apply.
We welcome applications from individuals who share our values and commitment to excellence.
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