Our Medical Device client, located in Greater Boston, has retained Weber & Company to help fulfill its Executive Director of Regulatory Affairs leadership position, which will open new markets and sustain its rapid growth.
With sales approaching $1B, the client is reasserting itself in the market by boosting its robust In Vitro Diagnostics (IVD) product development pipeline and forming a team of new leaders who bring innovation, progressive systems, and a "can-do-anything" mentality to its operating culture. Specifically, with the goal of being world-class in all phases of its business, our client presents an exceptional Regulatory Affairs career opportunity that allows you to make a real difference for both the company and the patient.
This position demands a hands-on Regulatory Executive who possesses strong business acumen, outstanding technical expertise, and the managerial skills needed to accelerate new product commercialization and develop a regulatory framework that strategically positions novel products in select global markets. You must enjoy contributing in a highly visible environment, building teams, and negotiating product approvals. Your leadership will help forge a new Regulatory culture that enhances credibility and fosters employee development. Reporting to the VP of Quality and Regulatory, you'll be the most qualified Regulatory expert on the Leadership team.
Core Accountabilities:
Lead all elements of Pre- and Post-Market Regulatory Affairs.
Establish accountability for results and manage the performance of an international team of regulatory professionals.
As the point person with the FDA, lead negotiations and oversee the Project Management of approvals and global registrations.
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.
Build and sustain a forward-thinking Regulatory culture.
Must-Have Requirements:
Demonstrated track record of achieving results.
Experience hiring and nurturing a team, both on-site and globally.
Well-rounded experience in obtaining product approvals across the global landscape; must have 510(k) experience; De Novo and 513(g) experience preferred.
Medical Device experience is essential; software-driven instrumentation, diagnostics product experience, and fluency in the IVDR are preferred.
Ability to work within a matrixed environment and influence global stakeholders and teams.
Action:
Our client offers a highly rated work environment, exemplified by low turnover, high employee satisfaction, and growth opportunities.
We look forward to sharing more about this exceptional opportunity that will turbo-charge your career!