Sr. Regulatory Affairs Specialist

Company: Philips
Location: Bothell
Posted on: January 14, 2021

Job Description:

Job TitleSr. Regulatory Affairs SpecialistJob DescriptionThe Sr. Regulatory Affairs Specialist provides regulatory leadership for BG Ultrasound product lines and is responsible to build and deliver on competitive regulatory strategies. The Regulatory Affairs Specialist works directly with regulatory agencies to achieve best possible outcomes for effective product market clearances. He / She is responsible for the coordination and preparation of document packages for regulatory submissions (FDA, Health Canada, EU Competent Authorities, CFDA, ANVISA, etc) and to recommend strategies for clinical studies and evaluations.You are responsible forServe as the Regulatory Affairs representative for the Ultrasound group and assists with regulatory issues related to such items as labeling and marketing ideas, prepares documents required in the Development Life Cycle, and recommends strategies for most efficient and effective approvals of regulatory applications for the business.Supports the cross functional teams with regulatory guidance during all design control phases of a new product or major changesIs directly responsible for the coordination and preparation of document packages for regulatory submissions to the US, EU and Canada [510(k) Pre-market Notifications, PMAs, Product Reports/Supplements, US Device Listings, GUDID (UDI), Technical Files, Declarations of Conformity, Medical Device Licenses] for all manufacturing sites.Provides guidance on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex X & ISO 14155, Canada Medical Device Regulations, etc.To succeed in this role, you should have the following skills and experience6 years of relevant experience in a medical device company (FDA Class I or II equivalent --- Class III a plus).6 years of experience with successful preparation and submission of 510(k), PMA, or international documents or registration and marketing of medical device worldwide.Bachelor---s degree in a technical / healthcare / business discipline or equivalent Strong working knowledge of medical device regulations (21CFR) and FDA law. Excellent English skills (written and oral).Certified regulatory affairs professional would be desirableBackground in Software as Medical Devices a PlusExperienced in design control processUS work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.You are a part ofPhilips imaging ultrasound machines bring innovative solutions to clinical complexity while simplifying workflow. Our suite of Ultrasound systems Philips Healthcare Ultrasound is designed to meet the many unique challenges --- you can make a difference in your new role every day. In return, we offer youWe offer you the opportunity to grow within the organization and Philips --- working cross functionally with R & D, on various projects and initiatives to drive our products to our customers and be a part of saving people---s lives every day.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 race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person---s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.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.Equal Employment and Opportunity Employer/Disabled/VeteranLI-PH1ContactIf you forgot your password, you can click the Forgot Password button on the Sign In screen to reset it. If you have any other questions regarding the recruitment process please refer to our FAQs. In case of technical difficulties with the website, please send an email to careersitephilips.com.(Note: To ensure fairness and legal compliance in our recruitment processes, only technical issues will be monitored through the above inbox. Please do not submit resumes or applications to this email, as they will not be reviewed. Only applications received through the online application process will be considered.) Full time

Keywords: Philips, Seattle , Sr. Regulatory Affairs Specialist, Other , Bothell, Washington