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Senior Director of Global Regulatory Compliance
3 weeks ago
Job Overview:
We are seeking an experienced Senior Director of Global Regulatory Compliance to lead our global regulatory strategy, driving compliance with international regulations and ensuring the success of our life science products.
The ideal candidate will have a strong background in regulatory affairs within the IVD industry, with experience in FDA submissions and negotiations. They will be responsible for developing and executing our global regulatory strategy, collaborating with cross-functional teams, and building a high-performing regulatory affairs team.
Key Responsibilities:
- Develop and execute comprehensive global regulatory strategies
- Lead and oversee all regulatory submissions to the FDA
- Negotiate with the FDA on regulatory matters
- Ensure successful clearance and compliance with IVDR requirements
- Oversee regulatory strategies and submissions in Canada
Requirements:
- Bachelor's degree in a scientific or technical discipline
- 10+ years of experience in regulatory affairs within the IVD industry
- Proven expertise in FDA regulatory submissions and negotiations
- In-depth knowledge of IVDR requirements
