Regulatory Operations Specialist
In this role, you have the opportunity to
Provide timely and valued global regulatory guidance to multiple new product development teams in Philips
You are responsible for:
- Create detailed written regulatory plans that can be used to target domestic and international shipment dates.
- Develop and prepare product registration submissions for the US, Canada, EU and select worldwide locations.
- Review and approve advertising, promotional items and labeling for regulatory compliance.
- Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
Additionally, the Regulatory Specialist will:
- Communicate application progress to internal stakeholders
- Collaborate with worldwide colleagues regarding license renewals and updates
- Assist with maintenance of regulatory files and tracking databases
- Participates in interaction with regulatory agencies on defined matters
To succeed in this role, you should have the following skills and experience
- At least 2 years of regulatory approvals and submittal experience (EU MDD, Health Canada, etc.)
- Must be able to manage multiple tasks and perform with accuracy and a high attention to detail
- RAPs RAC highly preferred
- Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision
- Working knowledge of domestic and international standards
- Experience with FDA 510(k) submissions is desirable
- Bachelors' degree required
- Proficient computer skills in Microsoft Office
- May require 5% travel annually with possibly some international
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 regard 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, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
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