Regulatory Affairs Director
3 days ago
Senior Director Regulatory Affairs
Job Summary
We are seeking a seasoned Senior Director Regulatory Affairs to lead our global regulatory function and drive strategic growth. As a key member of our leadership team, you will be responsible for developing and implementing a best-in-class regulatory program, aligning with our company's worldwide aspirations.
Key Responsibilities
- Develop and execute a global regulatory strategy, ensuring compliance with regulatory requirements and industry standards.
- Lead the planning and execution of regulatory submissions, including 510K, De Novo, and 513 Regs.
- Partner with business leaders to provide regulatory guidance and support the development of innovative products.
- Build and maintain relationships with regulatory bodies, including the FDA.
- Develop and implement a regulatory culture and mindset within the organization.
- Establish and maintain a regulatory framework that supports business growth and compliance.
Requirements
- Proven leadership experience in a senior Regulatory Affairs role, with a track record of driving strategic growth.
- Experience with Medical Device, diagnostics, IVDs, Software products, or similar products.
- Submissions experience (Global) – 510K, De Novo, 513 Regs.
- Prior history partnering with business leaders to provide regulatory guidance.
- Experience forming and implementing global regulatory strategies/programs.
About LDI Group
LDI Group is a global leader in innovative product development and advancement. We are committed to making the world a healthier place and are seeking a talented individual to join our team.
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