Regulatory Affairs Director

This is a fully remote position, open to applicants in California.

📋 Description

• Provide global leadership in the development and implementation of regulatory strategies for both new and existing Dental Solutions products.

• Act as a strategic partner to the business, shaping regulatory approaches that foster innovation, drive growth, and maintain market access.

• Influence product development and business strategies across various product portfolios.

• Evaluate regulatory pathways and market opportunities to guide investment and prioritization decisions.

• Identify regulatory risks and formulate mitigation strategies.

• Develop proactive regulatory strategies for novel and groundbreaking technologies.

• Create and execute regulatory strategies aimed at obtaining product approvals more swiftly than competitors.

• Direct complex regulatory decision-making processes among stakeholders and senior leaders.

• Provide advice and guidance on regulatory strategy development, interactions with regulatory authorities, and submission activities.

• Collaborate with Research & Development, Quality Assurance, and Clinical Affairs teams.

• Represent Regulatory Affairs in global business and functional strategic leadership meetings.

• Mentor and guide regulatory staff and teams.

• Set team goals and objectives that align with business strategies.

⛳️ Requirements

• A Bachelor's degree or higher (must be completed and verified prior to employment commencement).

• A minimum of ten (10) years of experience in Regulatory Affairs within the dental, medical device, or healthcare sectors.

• Must possess legal authorization to work in the country of employment without the need for sponsorship for employment visa status.

• A Master's degree in Science, Engineering, or a related technical field (this is an additional qualification).

• Proven experience in leading and developing global teams across multiple countries and regions.

• Experience in effectively communicating with stakeholders through verbal discussions, presentations, and written communications.

• Experience in supporting regulatory affairs activities across various countries, regions, and regulatory authorities.

• Experience working within complex matrix organizations and collaborating across functional teams.

• Willingness to travel up to 25% both domestically and internationally.

🏝️ Benefits

• Medical, Dental & Vision coverage.

• Health Savings Accounts.

• Flexible Spending Accounts for Health Care & Dependent Care.

• Disability Benefits.

• Life Insurance.

• Voluntary Benefits.

• Paid Absences.

• Retirement Benefits.

• Variable incentive pay, subject to eligibility.