Regulatory Affairs Specialist
3 weeks ago
ROLE SUMMARY
We are seeking a highly skilled Regulatory Affairs Specialist to join our Regulatory team at Optos. As a key member of our team, you will be responsible for assisting with the implementation and monitoring of a new regulatory intelligence process to ensure Optos meets global regulatory compliance requirements.
KEY RESPONSIBILITIES
- Monitor regulatory intelligence software for the latest updates on regulations and guidance.
- Assure compliance to GDPR, HIPAA, Sunshine Act, ICP, and other regulations.
- Support the team with the Net Zero plan and activities.
- Provide regulatory assistance in the development and registration of Optos products.
- Communicate effectively with external and internal parties, building strong relationships.
MINIMUM QUALIFICATIONS
- Degree in sciences, life sciences, engineering, or quality management.
- Excellent practical experience of regulatory submissions and requirements.
- Widespread experience in the highly regulated medical device market.
- Good awareness of FDA & MHRA systems and procedures.
- Previous knowledge of ISO / system is essential.
BENEFITS
At Optos, we offer a highly competitive compensation and benefits package.
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