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Regulatory Operations Specialist- Bothell, WA

In this role, you have the opportunity to

Advance expertise and knowledge of regulatory requirements in developing and drive regulatory strategies for high tech medical devices.

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.

• Advise product design teams on regulatory strategy requirements for specific new products/solutions.

• Supports development of the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements and product registrations such as CE Marking and clinical evaluations.

• 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.

• 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.

You are a part of

Philips is one of the world's leading healthcare technology companies. We are committed to understanding the technological and human needs of patients and caregivers and to delivering solutions that enable more confident diagnoses, more efficient delivery of care, and more positive user experiences. People focused. Healthcare simplified.

The Philips Emergency Care and Resuscitation business products include hospital Automated External Defibrillators (AED)/Monitoring equipment and portable Emergency Services/Public Access and Home AEDs. Our devices are able to automatically detect and recognize shockable heart rhythms in victims of sudden cardiac arrest. These technological breakthroughs allow the clinician to concentrate more on the patient and less on the device

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

• Bachelor’s degree in a technical discipline, or equivalent experience.

• RAPS RAC preferred.

• Minimum of 3-5 years of experience in the medical device industry (EU MDD/MDR, Health Canada, US FDA class II and class III, etc.) or equivalent experience in a related field.

• Strong background in Design Controls.

• Successful preparation of domestic and international medical device license 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.

• Effective working in multidisciplinary teams

• Good communication skills, written and verbal

• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

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. 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 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.

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.

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