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In this role, you have the opportunity to

Utilize your expertise and knowledge of regulatory requirements in developing and following –up closely the regulatory requirements for the markets international compliant with the new EU MDR requirements and impacted international markets.

The Regulatory Affairs Specialist will be responsible for supporting of a variety of regulatory activities and projects with oversight from senior regulatory staff.

Responsibilities include development, execution, and tracking of country packages and technical file remediation efforts and related regulatory project activities.

You are responsible for

• Being part and execute the regulatory compliance guidance by being the center of excellence in regulatory requirements and regulatory streamline operational process between Business groups /sites and Markets to ensure time to market on global initiatives related to EU MDR international markets impacted.

• Develop and maintain, execute and track elicit regulatory requirements as per each country required for regulatory compliance to EU MDR and international local regulations and tracking progress of project trackers for International markets impacted against planning, submissions and approvals deadlines

• Ensure a streamline LEAN process, system and tool between Business Groups and international Markets to ensure adequate accurate concise and clear regulatory information management in place.

• Work closely with cross-functional teams including Research and Development, Manufacturing, Quality Assurance, Marketing and international geographies to develop, design and deploy a regulatory flawless process and regulatory requirements. for a successful registration or re-certification in each related country,

• Track and assess current, new and changing regulatory requirements in international markets and assess on time the impact to deliverables and execution of the regulatory projects as assigned.

• Work closely with Regulatory Affairs Project Manage and International Regulatory Affairs Director and with Markets in International.

• Identify issues that need resolution to ensure continued registrations, maintenance in all International markets planned for commercialization

• Participate in cross-functional meetings to provide regulatory perspective and interpretative knowledge w.r.t. assigned projects.

• Knowledge of how to, or a willingness to learn to assess and analyze protocols, reports, and other documentation to support international registrations. The RA Specialist will work on problems of moderate complexity and diverse scope, including data analysis and ownership of task execution and completion.

You are a part of

You will have exposure to a multitude of medical devices, Business groups and sites and workflow solutions. This position partners with R&D, marketing, regulatory, quality, and legal among other functional areas where you will guide team members in application of all applicable regulatory requirements; ensuring documentation is adequate for successful regulatory submissions in each impacted country.

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

• An individual with a regulatory discipline as related to medical device products

• Scientific background ( engineer or scientific discipline) is preferred

• 3 + years of experience in international market in regulatory affairs

• 5+ years of experience in assembling the technical documentation files or design dossiers

• Deep knowledge about new EU MDR and differences to MDD

• Knowledge of International Markets.

• Experience in associated regulations relevant to labeling and use of international symbols

• Knowledge of regulatory requirements for CE marking and UDI

• Strong project management skills

• Ability to interpret applicable regulations to ensure compliance in a changing regulatory landscape

• Ability to work nimbly, innovative approach to problem solving

• Strong organizational skills, ability to work on multiple projects, and work effectively in a demanding, time-sensitive environment

• Effective working in multidisciplinary teams

• Good communication skills, written and verbal

• Detailed- oriented , Strong planning and organizational skills

In return, we offer you

We welcome you to a challenging, innovative environment with great opportunities for you to explore.

Our benefits are very competitive and designed around your preferences:

• A market conform salary

• 25 Days of leave and the possibility to purchase up to 20 extra days off annually

• A variable bonus based on both Philips results and personal performance

• Extensive set of tools to drive your career, such as a personal development budget, free training and coaching

• Solid company pension scheme and attractive collective health insurance package

• Opportunity to buy Philips shares and products with discount

• Healthy work-life balance

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there, you can also learn about our recruitment process , or find answers to some of the frequently asked questions .

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