Regulatory Affairs Business Manager

Regulatory Affairs Business Manager

Job Title

Regulatory Affairs Business Manager

Job Description

The Regulatory Affairs Business Manager is responsible for leading and executing regulatory compliance activities to ensure that Philips Oral Healthcare (OHC) products meet all applicable global regulatory requirements, standards, and internal policies. The role supports product development and lifecycle activities by planning and coordinating regulatory submissions, managing relationships with certification bodies, and deploying regulatory requirements across sites. Working closely with cross-functional teams including R&D/LCM, Quality, Manufacturing, and external partners, the role ensures timely approvals, risk mitigation, and sustained regulatory compliance throughout the product lifecycle.

Job Responsibilities

Regulatory Compliance & Certification

• Establish and maintain effective working relationships with global certification bodies and test houses (e.g., UL, DEKRA) to coordinate product testing, verification, and approvals for Philips Oral Healthcare products.

• Execute safety and regulatory compliance activities to ensure products comply with applicable regulations, international standards, and Philips policies.

• Plan, generate, and coordinate regulatory submissions to obtain and maintain product and solution licenses across global markets.

• Manage global product certifications and ensure ongoing compliance with certification requirements.

Regulatory Deployment & Intelligence

• Deploy regulatory requirements, standards, and regulatory memos to manufacturing and development sites, as applicable to the Personal Health business.

• Provide regulatory guidance and advisory support to cross-functional teams on applicable regulations, standards, and market-specific requirements.

• Monitor regulatory changes and contribute regulatory intelligence to support proactive compliance and business continuity.

Product Development & Lifecycle Management

• Implement applicable regulatory requirements in product development projects and lifecycle activities.

• Verify and validate product designs against regulatory and safety requirements to ensure compliance prior to market release.

• Review development quality plans, reports, and technical documentation to confirm adequacy for regulatory submissions and product compliance.

Cross-Functional Collaboration & Risk Management

• Actively collaborate with R&D, Lifecycle Management, Quality, Manufacturing, and other stakeholders to ensure regulatory requirements are embedded throughout the product lifecycle.

• Support internal and external audits and inspections, ensuring regulatory readiness and effective issue resolution.

• Identify and mitigate regulatory risks and contribute to continuous improvement initiatives within the regulatory framework.

Education

• Bachelor’s or Master’s degree in Biomedical Engineering, Health Sciences, Pharmaceutical Sciences, Business Administration, Law, or a related field (or equivalent).

Experience

• 10 years of experience in Regulatory Affairs, Quality Compliance, or Product Development within the medical devices industry.

• Demonstrated experience managing global regulatory activities and certifications.

Preferred Skills & Competencies (Success Factors)

• Strong experience in medical device regulatory compliance activities.

• Knowledge of RoHS, REACH, and global environmental regulations.

• Experience in research and development of new medical or consumer healthcare products.

• Working knowledge of IEC 60335, IEC 60601, EMC, and Radio standards.

How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
Indicate if this role is an office-based role.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.

Experience Level

Mid Level