Role Description
As the Regulatory Affairs Director, you will provide global leadership for the development and execution of regulatory strategies supporting new and marketed products within Dental Solutions, a growing business exceeding $1 billion in annual revenue. You will serve as a strategic partner to the business, shaping regulatory approaches that enable innovation, accelerate growth, and ensure continued market access across the portfolio.
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Developing and executing regulatory strategies to achieve product approvals faster than competitors.
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Directing complex decision making among stakeholders and senior leaders in areas of regulatory that are complex and evolving.
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Advising and guiding the regulatory strategy development, regulatory authority interactions, and submission activities to support the Dental Solutions product portfolios.
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Collaborating with internal teams, including R&D, Quality Assurance, and Clinical Affairs, to ensure regulatory requirements are integrated into product development and lifecycle management.
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Participating in global business and functional strategic leadership meetings and forums representing regulatory affairs perspective while supporting the business.
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Mentoring and guiding regulatory staff and teams working across all product modalities.
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Establishing goals and objectives for the team aligned with business strategies.
Qualifications
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Bachelor's degree or higher (completed and verified prior to start) AND ten (10) years of Regulatory Affairs experience in the dental, medical device, or healthcare industry.
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Master's degree in Science, Engineering, or a related technical discipline (completed and verified prior to start).
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Experience leading and developing global teams across multiple countries and regions.
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Experience communicating with stakeholders through verbal discussions, presentations, and written communications.
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Experience supporting regulatory affairs activities across multiple countries, regions, and regulatory authorities.
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Experience working within complex matrixed organizations and collaborating across functional teams to achieve business objectives.
Requirements
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Work location: Remote (United States)
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Travel: May include up to 25% domestic and international
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Relocation Assistance: Not authorized
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Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).
Benefits
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Expected compensation range for this position is $211,600 - $290,950, which includes base pay plus variable incentive pay, if eligible.
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This position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.).