Global Compliance Manager
1 week ago
Senior Manager, Regulatory Affairs - Structural Heart & Aortic (hybrid)
About the Role
We are seeking a seasoned Regulatory Affairs Professional to lead global regulatory strategies for transcatheter valve technologies at Medtronic. This role involves overseeing a team, collaborating with stakeholders, and ensuring compliance with regulatory requirements.
Key Responsibilities
- Develop and Implement Regulatory Strategies for transcatheter valve products, ensuring alignment with company goals and objectives.
- Lead a Team in regulatory approvals and submissions, providing guidance and support to ensure successful outcomes.
- Collaborate with Regulatory Authorities and stakeholders to ensure compliance with regulatory requirements and industry standards.
- Provide Guidance on regulatory requirements and compliance, ensuring that all team members are aware of and adhere to regulatory standards.
- Manage Regulatory Review of materials and product claims, ensuring that all regulatory requirements are met.
Requirements
- Bachelor's Degree with 7+ years of regulatory affairs experience, 5+ years of managerial experience.
- Advanced Degree with 5+ years of regulatory affairs experience, 5+ years of managerial experience.
Preferred Qualifications
- 10+ Years of Medical Device regulatory affairs experience.
- Advanced Degree in Regulatory Affairs or a technical field.
- Strategic Thinking and problem-solving abilities.
- Experience with global submissions.
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