Regulatory Afairs specialist

Be recognized as a key talent in International Regulatory filings and procedures.
Be considered a key regulatory point person enable the regulatory compliance in Markets where Philips Image Guided Therapy products are commercialized.
Be an impactful member of the Regulatory Affairs (RA) team and trusted by management as an independent regulatory team member on multiple projects simultaneously.
Function on a multi-geography basis, prioritize, conduct team meetings, and meet project deadlines.

You are responsible for

• Compile & review the necessary local/in country documentation for relevant stakeholders to complete registration activities.
• Provides information entry into regulatory databases, submissions software programs, AI regulatory intelligence and decision systems, and creates reports as required.
• Preparing and maintaining product registration files to obtain or to keep marketing approval and import licenses per local Regulatory requirements for CE marked/FDA cleared devices in the countries of IGT-D s distribution (EMEA, LATAM & APAC) to ensure that IGT-D s products comply with the regulations.
• Ensure completion of the International Registration Schedule and report progress per established KPIs to introduce new products and keep continuous products access to the Markets, under the guidance of a country specialist or regional manager.
• Preparing regulatory filings for new products, as well as significant post market changes. As necessary, reviews complex regulatory issues with RA manager.
• Manage records retention (Licenses/submissions) per company policy.
• Controls the distribution approvals process for products throughout the life cycle.
• Work with team members on regulatory intelligence & regulatory topics to support stakeholders.
• Assists implementation of global regulatory strategy and roadmaps through understanding the competitive market landscape and product marketing strategy.
• Engages in continuous learning activities to maintain technical competence in the product areas supported.
• Adopt a First-time right submission s culture (for Registrations, RE-Registrations and Renewals)
• Adopt an audit-ready culture.
• Identifying Process optimization to strengthen the International Regulatory Department and implement required improvements.
• Providing accurate and consistent regulatory recommendations, decisions, and feedback to RA stakeholders. Communicates with knowledge, consistency, and clarity to maintain integrity and impact of the message.
• Following Quality System procedures to ensure compliance with all other applicable regulations.
• Other duties as assigned.

You are a part of

• As a result of Philips renewed dedication to Patient Safety and Quality, it has recently restructured its organization to ensure you and your department have clear collaboration with Philips Business Group and Market leadership and can harness the expertise the Centers of Excellence (COEs). You are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being, and care for people around world.

To succeed in this role, you should have the following skills and experience

• Local work authorization is a precondition of employment.
• Excellent communication both written and verbal as well as have experience with communication and presentations to senior leadership.
• BS degree in relevant field. (BS, MS, or PhD in Engineering or Science preferred.)
• 2+ years of medical device experience with BS degree and work experience in Regulatory Affairs, or 3+ years of medical device experience with MS degree and work experience in Regulatory Affairs, or 2+ years of Regulatory Affairs experience with PhD in Engineering/Science.
• Demonstrated experience in multiple types of International regulatory submissions (Europe, South Korea, Taiwan, Kingdom of Saudi Arabia, Brazil, Russia, Australia, Mexico, Singapore, India, among others)
• Must have working knowledge of FDA, ISO 13485, EU MDR, and other applicable regional regulations for handling complaints, reporting incidents, and implementing corrective and preventative actions.
• Ability to makes decisions in a timely manner, sometimes with incomplete information and under tight deadlines.
• Knowledge of PC hardware/software, documentation, and archives (Proficiency in Microsoft Office Suite, particularly Word and Excel)
• Languages: English (written and spoken), knowledge of other languages is an asset