Philips Regulatory Affairs Specialist (Medical Device) in Carlsbad, California
Regulatory Affairs Specialist
(Medical Device background is required)
Great innovations start with the people that are passionate and skilled enough to create them. As a diversified health and well-being company, Philips focuses on improving people’s lives through those timely and meaningful innovations.
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
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.
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.
We are looking for:
The successful candidate will possess the following knowledge, skills education 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.
Here at Philips WE ARE Working Together for a Better Tomorrow:
Philips' dedication to enriching lives is reflected in our company, our solutions, and a commitment to our people. Philips products lead to improved healthcare, faster diagnosis and better patient outcomes. Philips employees change lives every day.
Enjoy endless opportunities to learn, and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what’s next. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to create your own legacy.
Call to Action / Contact
Advance your career in an environment that supports work-life balance, health & well-being and continuous learning. Making a difference begins right here, where you come first.
Ready to start improving lives by putting your personal skills & passions to work?
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.