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International Regulatory Affairs Specialist

PhilipsJobsNA Philips

Philips is a leading health tech company, improving people’s health and enabling better outcomes across the health continuum—from healthy living and prevention to diagnosis, treatment, and home care.

Job Title
International Regulatory Affairs Specialist

Job Description

Effective Wednesday, December 8, 2021, all U.S.-based employees are required to be fully vaccinated against COVID as a condition of employment at Philips. Employees with a sincerely held religious belief and/or disability impacting their ability to obtain the COVID vaccine can request a reasonable accommodation.

If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact 888-367-7223, option 5, for assistance.

Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.

But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common: An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.

The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

In this role, you have the opportunity to make life better

Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.

In this role, you have the opportunity to

  • Be recognized as a key talent in International (Excluding USA and Japan) Regulatory filings and procedures. Potential to transition into an internal subject matter expert in a regulatory geography and knowledgeable in a 2nd geography.
  • 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 project simultaneously.
  • Support multiple projects, function on a multi-geography basis, prioritize, conduct team meetings, and meet project deadlines.

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.

You are a part of

As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces 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.

To succeed in this role, you’ll need a customer-first attitude and the following

  • BS degree in relevant field. (BS, MS, or PhD in Engineering or Science preferred.)
  • 5+ 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.
  • Excellent communication both written and verbal as well as have experience with communication and presentations to senior leadership.
  • 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

How we work at Philips

  • Our newly adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles.
  • Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.
  • Our hybrid working model is defined in 3 ways:
  • We believe in the importance of impactful collaboration: There’s a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.
  • We embrace flexibility: Choosing where, when, and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams, and our customers on a case-by-case basis.
  • We want to be at our best: The way we work, and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.

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 innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

Visit our careers website to explore what it’s like working at Philips , read stories from our employee blog , find information about our recruitment process and answers to some frequently asked questions .

It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.

As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans’ Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

Equal Employment and Opportunity Employer/Disabled/Veteran

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It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.

As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans’ Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.
Equal Opportunity Employer/Disabled/Veteran

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International Regulatory Affairs Specialist

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Philips

Philips is a leading health tech company, improving people’s health and enabling better outcomes across the health continuum—from healthy living and prevention to diagnosis, treatment, and home care.

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