Philips Regulatory Affairs Manager in Bothell, Washington
Prepare, review, and finalize reports, labeling and other documents for formal submission to regulatory agencies
Consider suitability of documentation for regulatory filings, identifying gaps as compared to relevant regulatory requirements, and facilitate obtaining outstanding elements across internal departments
Organize key project information and track activities along project plans
Prepare research and other materials to assist senior staff with regulatory agency meetings and official communications
Develop and maintain knowledge of regulatory requirements and current industry practice for regulatory submissions
Assist in maintaining state, federal and international licenses, registrations and listings
Assist in achieving Competent Authority Notifications in support of Clinical Trials
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 the role of Sr. Regulatory Affairs Specialist you will be working in a global environment that is instrumental in supporting the innovation within our Ultrasound group.
In this role, as Sr. Regulatory Affairs Specialist you will be responsible for the following:
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
EU MDR requirements
Drives 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.
Philips is a leading health technology company focused on improving people’s health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. The company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Headquartered in the Netherlands, Philips posted 2015 sales of EUR 16.8 billion and employs over 70,000+ employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter .
We Are Looking For:
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.
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.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.