Regulatory Affairs Business Manager
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Job Location:
Monthly Salary:
Posted on:
17 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Title
Regulatory Affairs Business ManagerJob Description
The Regulatory Affairs Business Manager is responsible for leading and executing regulatory compliance activities to ensure that Grooming and Beauty 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
Bachelors or Masters 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 companys facilities.
Field roles are most effectively done outside of the companys 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 wont 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 youre 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 Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Philips has been revolutionizing lighting for over 125 years. We pioneered the world changing development of electric light and LED, and are now leading the way in intelligent lighting systems. Our deep understanding of how lighting positively affects people, enables us to deliver inn ... View more
