Job Title

Regulatory Affairs Business Specialist

Job Description

The Regulatory Affairs Business Specialist supports the Regulatory Affairs function in ensuring that products in Mother and Child Care/Women's Health comply with applicable global and local regulatory requirements and standards throughout the product lifecycle. This role is responsible for supporting regulatory submissions, maintaining compliance documentation, reviewing labeling and promotional materials, and coordinating regulatory activities related to product changes. Working closely with cross-functional teams including R&D, Lifecycle Management (LCM), Quality, Marketing, and Manufacturing, the role contributes to maintaining regulatory compliance and enabling timely product availability.

Key Responsibilities

Regulatory Compliance & Lifecycle Support

• Take ownership of regulatory activities related to product changes during the lifecycle management phase, ensuring regulatory compliance data is accurate, complete, and up to date.

• Support product registrations, approvals, and change notifications in accordance with applicable regulatory requirements.

• Administer compliance protocols during MLD and lifecycle management activities, including safety certifications and country-specific approvals.

• Maintain regulatory files, databases, and documentation to ensure readiness for internal and external audits and inspections.

Documentation & Review

• Prepare, review, and submit regulatory documentation under the guidance of senior Regulatory Affairs team members.

• Review product labeling, packaging, and promotional materials to ensure compliance with regulatory guidelines and applicable standards.

• Support document review and auditing activities to ensure adherence to company policies and regulatory requirements.

Cross-Functional Collaboration

• Collaborate closely with local R&D, LCM, Quality, Marketing, and Manufacturing teams to ensure regulatory requirements are met throughout the product lifecycle.

• Coordinate and facilitate product testing activities to ensure compliance with safety and performance regulations, maintaining direct contact with external test houses as needed.

Regulatory Intelligence & Continuous Improvement

• Support the implementation of changes in relevant regulations and standards to maintain ongoing compliance.

• Contribute to continuous improvement initiatives within the regulatory framework and proactively support regulatory risk management activities.

• Demonstrate a general understanding of the regulator’s role within the Quality System and awareness of the product portfolio and business environment.

Education

Bachelor’s or master’s degree in biomedical engineering, Health Sciences, Pharmaceutical Sciences, Business Administration, Law, or a related discipline (or equivalent).

Experience

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

Knowledge & Skills (Success Factors)

• Knowledge of medical device regulatory requirements and compliance activities.

• Familiarity with relevant medical device standards, such as IEC 60601 series, ISO 14971, and IEC 62304.

• Experience with document review, auditing, and product registrations.

• Understanding of regulatory intelligence and regulatory change management.

• Strong stakeholder management and cross-functional collaboration skills.

• Ability to support risk mitigation strategies and continuous improvement initiatives.

• Project management skills with attention to detail and accountability.

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.