Regulatory Affairs Manager
Job TitleRegulatory Affairs Manager
We welcome you to join Philips Ultrasound as an Regulatory Affairs Manager in our Bothell, WA location
In this role, you will be working with our Ultrasound product line Philips Healthcare Ultrasound
- Driving improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System.
- Review and recommend changes for design process and manufacturing procedures to maintain quality and regulatory compliance
- Provide guidance to BG US on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex X, ISO 13485 and ISO 14155, Canadian CMDCAS, compliance with FDA's guidance documents etc.
- Responsible for ensuring compliance with the current IS regulatory procedures and updating the procedures when new regulatory requirements become effective.
- Provide regulatory support for (pre-) clinical studies, including recommending strategies to optimize clinical study approvals and review of clinical study protocols.
- Advise BG US on regulatory policy (for market release) in line with Philips regulatory policy;
- Represent Philips in an international committee chartered to develop an applicable standard.
You are responsible for
- Assisting Business Group (BG) Ultrasound (US) in the development of regulatory strategy and regulatory roadmap, such as CE Marking, 510(k), IDE, Pre-submission applications and supporting WW registration.
- Leading Regulatory Affairs Council meeting to ensure the council members are apprised of new and upcoming regulatory requirements, and be a liaison for collecting information from BIUs to support Quarterly management reviews or any other metrics requested by Management.
- Keep abreast of current regulatory procedures and changes. Participates in direct interaction with regulatory agencies on defined matters.
- Recommend and assist BG US in the development of strategies for:
- IDE and Clinical trials applications in accordance with MDD Annex X, ISO 14155 standard.
- Traditional, abbreviated or special 510(k)s
- Pre-market Approval Applications
- WW registrations
- EU MDR requirements
You are a part of
In today's challenging and changing healthcare environment, clinicians need every image to contribute to a confident diagnosis and every moment to matter in the clinical workflow.
Philips 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.
To succeed in this role, you should have the following skills and experience
- Bachelors of Science degree in a technical or business discipline.
- Minimum of 8 years of experience in a medically regulated and technical environment with at least 5 years in a medical device company (FDA Class I or II equivalent and Class III).
- Must have experience with successful preparation and submission of Technical File, Design Dossiers, 510(k), PMA, and international documents or registration of medical device worldwide.
- Knowledgeable of MDD and MDR, ISO13485, Q and, IDE, 510(k) premarket notification.
- Excellent working knowledge of medical device regulations (21CFR), FDA law and CE marking
- Experience in supporting international registrations.
- 4+ years of experience preparing, reviewing, and filing U.S. medical device regulatory submissions, including 510(k)s, PMAs, and Q-submission filings
- Degree in science (biology, biochemistry, chemistry, microbiology, immunology, pharmacology), engineering, medical-related or health-related field preferred
- Regulatory Affairs Certification (US) through RAPS preferred
- Experience successfully securing a number of FDA clearances and approvals
- Strong working knowledge of FDA regulations, including knowledge of medical device development process and related FDA regulations across full product life cycle
- Experience with ISO 14155 and other clinical regulatory requirements is a plus
- High level of proficiency with MS Word and Adobe DC for document preparation
- Exceptional attention to detail and well-developed analytical thinking skills
- Exceptional project organization and time management skills, including the ability to prioritize multiple competing project timelines while ensuring all deadlines are met
- Ability to take initiative and work autonomously without significant direction, implementing independent judgment to determine objectives of a variety of projects
In return, we offer you
We 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. Learn more about the testing process Ultrasound
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.
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, and 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
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