Regulatory Affairs Business Manager Full Time

Regulatory Affairs Business Manager

Job Description

The Regulatory Affairs Business Manager is responsible for leading and executing regulatory compliance activities to ensure that Personal Health Business (Oral healthcare, Grooming & Beauty, Mother and Childcare) products meet all applicable global regulatory requirements, standards, and internal policies.

The role supports product development and lifecycle management 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 Profile Summary

• The Regulatory Affairs Business Specialist 60 supports the regulatory affairs team in ensuring that products comply with all relevant regulations and standards.
• Responsible for preparing and submitting regulatory documentation, maintaining records, and supporting product registrations and approvals under the guidance of senior team members.
• Advises on the deployment of changes in regulatory requirements and standards to maintain compliance.
• Reviews product labeling, packaging, and promotional materials to ensure regulatory compliance.
• Supports internal and external audits and inspections as required.
• Collaborates closely with R&D/LCM, Quality, and Manufacturing teams to ensure regulatory requirements are met throughout the product lifecycle.

Key Responsibilities

• Establish and maintain relationships with global certification bodies (e.g., DEKRA, UL) and coordinate approval, testing, and verification processes related to Philips OHC products.
• Execute regulatory and safety compliance activities to ensure products comply with all applicable regulations and Philips policies.
• Deploy regulatory requirements and guidance across relevant sites for Personal Health.
• Participate in and advise cross-functional teams on regulatory requirements, standards, and market-specific regulations.
• Implement relevant regulatory requirements in product development projects and ensure verification and validation of product designs.
• Review development quality reports and project plans to confirm readiness for regulatory submissions and product compliance.
• Plan, prepare, and coordinate regulatory submissions for product licensing and approvals.

Preferred Skills (Highest Priority)

• Regulatory compliance activities
• Knowledge of RoHS, REACH, and global environmental regulations
• Experience in product research and development
• Knowledge of IEC 60335, IEC 60601, EMC, and Radio standards
• Understanding of Biocompatibility ISO 10993
• Experience working with certification bodies (e.g., UL, DEKRA)
• Experience with global product certifications
• Strong analytical capabilities and product knowledge
• Ability to collaborate effectively across multiple business functions
• Experience with product registrations
• Knowledge of product labeling regulations

Preferred Skills (Secondary Priority)

• Strategy implementation
• Stakeholder management
• Regulatory intelligence
• Risk mitigation strategies
• Project management or managerial experience

Education Requirements

Bachelor’s or master’s Degree in one of the following:

• Biomedical Engineering
• Business Administration
• Health Sciences
• Pharmaceutical Sciences
• Law
• Or equivalent field

Experience Requirements

Minimum 4 years of experience in one or more of the following areas within the similar regulated industry:

• Regulatory Affairs
• Quality Compliance
• Product Development

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.