Philips Regulatory Affairs Specialist (Medical Device) in Carlsbad, California

Regulatory Affairs Specialist

In this role, you have the opportunity to

Help build a high growth business that will help improve the lives of millions of people while advancing Philips journey as a global leader in Health Technology.

You are responsible for

New Product Development

  • The Regulatory Specialist 4 is a core team member on product development teams. The Regulatory Specialist 4 will provide regulatory guidance by creating detailed written regulatory plans based on the Marketing Product Launch Plan for initial domestic and international product launch.

  • Responsible for US and International Product Registrations/approvals.

  • Recommend and develop strategies for:

  • 510(k)s or Pre-market Approval applications

  • Pre-Submission applications

  • International product registrations

Preparing for Product Launch

  • Develop, prepare and submit regulatory documentation for the countries indicated in the Marketing Product Launch Plan.

  • Responsible for the coordination and preparation of document packages: 510(k) or PMA applications, Technical Files for CE marking, and International product registrations.

Market Expansion for Existing Products

  • After the initial product launch, the market for a given medical device is intended to grow through market expansion.

The Regulatory Specialist 4 will enable this market expansion by developing, preparing and submitting additional product registrations for the countries indicated in the Market Expansion Plan.

  • Associated Duties

  • Communicate application progress to internal stakeholders

  • Collaborate with worldwide colleagues regarding license renewals and updates

  • Communicate with regulatory agencies as needed

  • Identify and communicate potential risks to the existing regulatory approvals based on changes in country / regional requirements.

  • Maintain Regulatory records as required

  • Review and approve engineering and labeling changes for compliance to regulatory requirements. Write 510(k) Letters to File for appropriate engineering changes.

  • Ensure that training assignments are completed in a timely manner.

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

  • Bachelor’s/Master’s degree in a related field preferred, or 6 or more years of hands-on experience with medical device Regulatory Approvals.

  • Must have personal experience with preparation and submission of successful 510(k) or PMA submissions and International registrations.

  • Minimum of 6-10 years of experience in medical device Regulatory Approvals: US FDA Class II/III, EU MDD, Health Canada, and International registrations.

  • Proficient knowledge of medical device regulations: FDA, MDD, global product approval requirements, and standards that are required for product approval.

  • RAPs RAC preferred.

  • Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions and interface interdepartmentally.

  • Proficient computer skills in Microsoft Word and Adobe Acrobat.

  • May require 5% travel annually with some international travel possible.

In return, we offer you

A path towards your most rewarding career. Succeeding in this 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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . 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 at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .

Find out more info about Philips at www.philips.com/na/careers

Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.

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.

#LI-SD1

Regulatory Affairs Specialist

In this role, you have the opportunity to

Help build a high growth business that will help improve the lives of millions of people while advancing Philips journey as a global leader in Health Technology.

You are responsible for

New Product Development

  • The Regulatory Specialist 4 is a core team member on product development teams. The Regulatory Specialist 4 will provide regulatory guidance by creating detailed written regulatory plans based on the Marketing Product Launch Plan for initial domestic and international product launch.

  • Responsible for US and International Product Registrations/approvals.

  • Recommend and develop strategies for:

  • 510(k)s or Pre-market Approval applications

  • Pre-Submission applications

  • International product registrations

Preparing for Product Launch

  • Develop, prepare and submit regulatory documentation for the countries indicated in the Marketing Product Launch Plan.

  • Responsible for the coordination and preparation of document packages: 510(k) or PMA applications, Technical Files for CE marking, and International product registrations.

Market Expansion for Existing Products

  • After the initial product launch, the market for a given medical device is intended to grow through market expansion.

The Regulatory Specialist 4 will enable this market expansion by developing, preparing and submitting additional product registrations for the countries indicated in the Market Expansion Plan.

  • Associated Duties

  • Communicate application progress to internal stakeholders

  • Collaborate with worldwide colleagues regarding license renewals and updates

  • Communicate with regulatory agencies as needed

  • Identify and communicate potential risks to the existing regulatory approvals based on changes in country / regional requirements.

  • Maintain Regulatory records as required

  • Review and approve engineering and labeling changes for compliance to regulatory requirements. Write 510(k) Letters to File for appropriate engineering changes.

  • Ensure that training assignments are completed in a timely manner.

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

  • Bachelor’s/Master’s degree in a related field preferred, or 6 or more years of hands-on experience with medical device Regulatory Approvals.

  • Must have personal experience with preparation and submission of successful 510(k) or PMA submissions and International registrations.

  • Minimum of 6-10 years of experience in medical device Regulatory Approvals: US FDA Class II/III, EU MDD, Health Canada, and International registrations.

  • Proficient knowledge of medical device regulations: FDA, MDD, global product approval requirements, and standards that are required for product approval.

  • RAPs RAC preferred.

  • Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions and interface interdepartmentally.

  • Proficient computer skills in Microsoft Word and Adobe Acrobat.

  • May require 5% travel annually with some international travel possible.

In return, we offer you

A path towards your most rewarding career. Succeeding in this 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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . 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 at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .

Find out more info about Philips at www.philips.com/na/careers

Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.

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.

#LI-SD1