Job TitleRegulatory Affairs Specialist Operational Excellence - EU MDR
In this role, you have the opportunity to
Utilize your expertise and knowledge of regulatory requirements in developing and closely managing the regulatory requirements for the international markets compliance with the new EU MDR requirements
You are responsible for
Executing the regulatory compliance operations in markets in a center of excellence in regulatory requirements and streamline regulatory operational process between Business groups /sites and Markets
• Elicit, maintain, execute and track regulatory requirements as per each country requirement for regulatory compliance to EU MDR as impacted
• Ensure a streamlined LEAN process, system and tool between Business Units and international Markets to ensure adequate, accurate, concise and clear regulatory information management
• Work closely with cross-functional teams including Research and Development, Manufacturing, Quality Assurance, Marketing and international geographies to develop, design and deploy a regulatory Lean process, 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 Manager and International Regulatory Affairs Director and with Markets in International
• Identify issues that need resolution to ensure continued registrations and maintenance of registrations in all International markets
• 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
You are a part of
A fast growing and innovative team, with exposure to a multitude of medical devices, Business groups and sites and workflow solutions. This position collaborates 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
•A minimum of a Bachelor’s Degree (B.S. or B.A.) in Science, Engineering, or related discipline
Experience with a regulatory discipline as related to medical device products
• 3 + years of experience in International market in regulatory affairs or a European country with solid track record
• 5+ years of experience in assembling the technical documentation files or design dossiers
• Deep knowledge about new EU MDR and differences to MDD
• 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
• Interest in and passion for the medical device industry, bringing innovation to market
• Detailed- oriented , Strong planning and organizational skills
In return, we offer you
A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this market-based role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.
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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