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Regulatory Affairs Manager
2 months ago
Terumo Aortic is seeking a highly skilled Regulatory Affairs Team Leader to drive regulatory strategy and compliance for our products.
Key Responsibilities:
- Develop and implement regulatory plans and strategies for new products and changes to existing products.
- Prepare and review regulatory documentation and submissions for product approval.
- Participate in Design Control, Risk Management, and Post Market Surveillance activities.
- Review and prepare regulatory paperwork in accordance with International standards and new regulations.
- Collaborate with cross-functional teams to ensure regulatory compliance.
- Provide regulatory input to functional groups as required.
- Mentor and develop Regulatory Affairs Associates.
Requirements:
- BSc Hons Degree or equivalent in a relevant field.
- Proven experience in Regulatory Affairs, preferably in a medical device industry.
About Terumo Aortic:
We are a leading manufacturer of medical devices, committed to delivering innovative solutions that improve patient outcomes.
