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Originele vacaturetekst

Regulatory Affairs Specialist

Job Description

In this role, you have the opportunity to

Be recognized as a key talent in International Regulatory filings for Philips Image Guided Therapy, medical device products and procedures and considered as a key regulatory point person enable the regulatory compliance in the Markets. In this job, you support multiple projects, function on a multi-geography basis, prioritize, conduct team meetings, and meet project deadlines. This role is an additional role, because the department is growing and developing.

This job can be done from Belgium (office location) or home remotely.

You are responsible for

  • Preparing regulatory strategies for new devices, new registrations and re-registrations/notifications due to product changes, regulatory changes, changes in Go2Market model. Clearly communicates strategies to RA management and core teams.
  • Preparing and submitting 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) in order to ensure that IGT-D’s products comply with the regulations
  • Expanding your regulatory knowledge of the geographies you are responsible for, liaising with local Philips Entities, Distributors, local Trade Associations and other Sources of Regulatory Intelligence
  • Identifying Process optimization to strengthen the International Regulatory Department.
  • Preparing regulatory filings for new products, as well as significant post market changes. As necessary, reviews complex regulatory issues with RA manager.
  • Providing accurate and consistent regulatory recommendations, decisions, and feedback to product development and manufacturing teams.
  • Able to identify risks within regulatory strategies and clearly communicate risks to projects teams and RA management
  • Able to professionally negotiate and lead meetings with internal and external customers (Marketing, R&D, Markets, Distributors). All significant issues are negotiated with the RA Manager.
  • Following Quality System procedures to ensure compliance with all other applicable regulations.
  • Maintaining proficiency in broad, regional regulatory requirements. Develop general strategies on more effective interactions with government agencies and agency personnel.
  • Assisting the RA Manager with training of more junior specialist staff.
  • Potential growth opportunity to transition in to an internal subject matter expert in a regulatory geography and knowledgeable in a 2nd geography.

You are a part of

As a result of Philips renewed dedication to 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 of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, 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.

In this role you will be an impactful member of the Regulatory Affairs (RA) team and trusted by management as an independent regulatory team member on multiple project simultaneously.

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

  • BS degree in relevant field. (BS, MS, or PhD in Engineering or Science preferred.)
  • 3-5 years of medical device experience and work experience in Regulatory Affairs
  • Excellent communication both written and verbal as well as have experience with communication and presentations to senior leadership.
  • Preferrable experience in multiple types of International regulatory submissions (China, Korea, Saudi Arabia, Brazil, Russia, Australia, Colombia, Singapore, India, among others)
  • Working knowledge of FDA, ISO, EU, and/or 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

In return, we offer you

A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global 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. Furthermore, Philips University is available to all employees for learning and development opportunities.

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.

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.

It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation. Philips is an equal opportunity employer committed to a diverse workforce.


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