Regulatory Affairs Director
16 hours ago
Job Summary:
Weber & Company is seeking an experienced Executive Director Regulatory Affairs to lead our client's regulatory affairs team in Greater Boston. As a key member of the leadership team, you will be responsible for developing and implementing a regulatory strategy that accelerates product approvals and maintains a competitive advantage.
Key Responsibilities:
- Lead all elements of Pre- and Post-Market Regulatory Affairs, including negotiations with the FDA and global registrations.
- Establish accountability for results and manage the performance of an international team of regulatory professionals.
- Advise Executive Management and the Board on global Regulatory Strategy.
- Develop a progressive regulatory framework that accelerates product approvals while maintaining a competitive advantage.
- Enhance Regulatory Intelligence and build a forward-thinking Regulatory culture.
Requirements:
- Demonstrated track record of achieving results in a matrixed environment.
- Experience hiring and nurturing a team, both on-site and globally.
- Well-rounded experience in obtaining product approvals across the global landscape, including 510(k) experience, De Novo and 513(g) experience preferred.
- Medical Device experience is essential, with software-driven instrumentation, diagnostics product experience, and fluency in the IVDR preferred.
What We Offer:
Our client offers a highly rated work environment, exemplified by low turnover, high employee satisfaction, and growth opportunities. If you are a motivated and experienced Regulatory Affairs professional looking to make a real difference, we encourage you to apply for this exceptional opportunity.
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