Philips Regulatory Affairs Specialist in Bothell, Washington
Entry level position.
Detailed job description attached.
You are responsible for:
The Regulatory Affairs Specialist will provide timely and valued regulatory guidance (written and / or verbal) by owning the following tasks:
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 engineering changes, 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.
Provide audit and CAPA support
Additionally, the Regulatory Specialist will:
Communicate application progress to internal stakeholders
Collaborate with worldwide colleagues regarding license renewals and updates
Maintain regulatory files and tracking databases
Collaborate with senior regulatory affairs specialists to create more complex submissions
Communicate with regulatory agencies as needed
To succeed in this role, you should have the following skills and experience
Bachelor’s degree preferred, but not required.
Minimum of 2 years of experience in the medical device industry (EU MDD, Health Canada, US FDA class II and class III, etc.) or equivalent experience in a related field.
Working knowledge of domestic and international medical device approval requirements.
Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision.
Must be able to manage multiple tasks and perform with accuracy and a high attention to detail.
Proficient computer skills in Microsoft Office.
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. Learn more by watching this video .
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/philips-recruitment-process.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .
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.