Sr. Regulatory Affairs Specialist
Company: Philips
Location: Bothell
Posted on: January 14, 2021
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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
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