Regulatory Affairs Business Manager
Philips•15h ago
PuneOnsiteFull-timeSenior Level10+ yrs exp
Top focus
Regulatory AffairsBusiness Ops ManagerBusiness AnalystHr Business Partner
- 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
- internal policies. The role supports product development and lifecycle activities by planning and coordinating regulatory submissions, managing relationships with certification bodies
- deploying regulatory requirements across sites. Working closely with cross-functional teams including R&D/LCM, Quality, Manufacturing
- external partners, the role ensures timely approvals, risk mitigation
- 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
- approvals for Philips Oral Healthcare products. Execute safety and regulatory compliance activities to ensure products comply with applicable regulations, international standards
- Philips policies. Plan, generate
- 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
- 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
- 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
- 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
- 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
- a related field (or equivalent). Experience 10 years of experience in Regulatory Affairs, Quality Compliance
- 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
- global environmental regulations. Experience in research and development of new medical or consumer healthcare products. Working knowledge of IEC 60335, IEC 60601, EMC
- 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
- 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 .
Required skills
Regulatory AffairsQuality ComplianceProduct DevelopmentBiomedical EngineeringHealth SciencesPharmaceutical SciencesLawRoHSREACHIEC 60335IEC 60601EMC