Regulatory Affairs Project Manager - EU MDR

Job Description

Job Title

Job Description

In this role, you have the opportunity to

Work for a progressive and dynamic company within the medical device industry in a challenging global regulatory environment. You will develop and communicate a vision for the Regulatory Affairs function to management, including the development of global regulatory strategy in the area of regulatory submission pertaining to EU MDR for international markets as impacted and to project management of process between Business groups and markets.

You are responsible for

The Project regulatory Manager International Markets is responsible for regulatory activities to support new products introduction in addition to throughout life cycle maintenance in line of products under the scope of EU MDR mainly for the international countries.

• Represent regulatory affairs Markets in the program board for EU MDR PMO for related regulatory activities in coordination with International Regulatory Affairs Director. Providing the global regulatory plan, regulatory assessments and regulatory decisions and strategic regulatory including an action plan for EU MDR and impacted countries
• Engaging the businesses groups and sites at Philips to be prepared for EU MDR and for international markets as impacted by providing solutions and risk assessment
• Develop an action plan with a streamlined operational mechanism and process in place to ensure readiness of submission and packages to countries
• Coordinate with the markets team (Regulatory and Quality) international and with business groups and sites to ensure LEAN communication and elicit country requirements in a proper project and ensure a LEAN operational mechanism between Markets international and Business groups/ sites
• Optimize regulatory operations driving LEAN culture in regulatory with methods such as problem solving, daily management and Kaizen
• Plan schedules for regulatory deliverables on a project and monitor projects through completion
• Track the execution of the projects and develop dashboards and reports for communication across the organization
• Manage global regulatory strategies and impact assessments of changes that may affect regulatory approvals with regard to projects assigned
• Assist with the maintenance of the regulatory database with accurate and current regulatory information.
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times
• Provide Regulatory Affairs support during internal and external audits as applicable

You are a part of

A highly advanced and entrepreneurial team, coordinating and leading a team of regulatory subject matter experts supporting various new and sustaining programs located in all international Markets and across the globe.

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

• Advanced degree preferred, PMP and/or RAPS certification preferred
• A minimum of 8 years of regulatory experience within an EU MDD medical device regulated industry
• Knowledge of EU regulatory requirements including the MDD and MDR for medical devices is preferred
• Practical experience in a medical device Regulatory Environment is required; preparing international submissions for medical devices and a successful record of accomplishment is required
• Ability to work as a member of a team in a timeline-driven environment with limited supervision is required
• Being detail-oriented while having the ability to handle multiple ongoing projects/tasks is required
• Excellent interpersonal communication, collaborative teamwork, conflict management and negotiation skills
• Ability to build trusting relationships with all levels of management and presenting proposals to executives
• Demonstrated ability to mentor, train, and develop indirect team members

*Travel as needed up to 10%

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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