Director of Regulatory Compliance-Oral Healthcare

Philips•Bothell, WA

5d•$172,200 - $275,520•Hybrid

About The Position

The Director of Regulatory Compliance is responsible for formulating and executing comprehensive global regulatory strategies and roadmaps, ensuring alignment with Oral Healthcare business objectives and competitive market analysis. This role involves developing global regulatory strategies by creating and implementing regulatory roadmaps aligned with market trends, legislation, and product marketing objectives. The position requires staying current on evolving regulations to advise senior leadership on strategic decisions. The Director will act as the business unit contact with regulatory bodies, ensuring clear communication and fostering relationships to influence decisions and secure approvals. Additionally, the role includes leading the regulatory compliance team by providing guidance, managing talent, and driving succession planning and growth while maintaining compliance and achieving organizational goals. The Director will ensure compliance across the product lifecycle by overseeing regulatory planning and execution for new products and changes, as well as managing filings and approvals by overseeing the preparation and submission of documentation for global registrations to enable timely market access. Finally, the role drives regulatory excellence and continuous improvement by developing plans, assessing risks, implementing actions, and optimizing regulatory processes for efficiency while maintaining high compliance standards.

Requirements

Minimum of 12+ years' experience in Regulatory Affairs within FDA regulated Medical Device/Consumer electronics environments.
Minimum of 6+ years as a functional/strategic leader, including mentoring, training, succession planning, hiring, performance management, technical/professional development of team members.
Demonstrated Global Regulatory Domain knowledge/expertise in overseeing the preparation/submission of regulatory filings/documentation, global product registrations/approvals and leading others in global regulatory matters of diverse product categories - Class I medical device, consumer goods and cosmetics.
Able to communicate, influence and build relationships with Internal/External Stakeholders, regulatory authorities and industry organizations at all levels.
Minimum of a Bachelor’s Degree (Required).
Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

Nice To Haves

Master’s degree/MBA desired.

Responsibilities

Develop global regulatory strategies by creating and implementing regulatory roadmaps aligned with market trends, legislation, product marketing objectives and staying current on evolving regulations to advise senior leadership on strategic decisions.
Act as the business unit contact with regulatory bodies, ensuring clear communication and fostering relationships to influence decisions and secure approvals.
Lead our regulatory compliance team by providing guidance, managing talent, and driving succession planning and growth while maintaining compliance and achieving organizational goals.
Oversee regulatory planning and execution for new products and changes as well as managing filings and approvals by overseeing preparation and submission of documentation for global registrations to enable timely market access.
Develop plans, assess risks, implement actions, and optimize regulatory processes for efficiency while maintaining high compliance standards.