Philips Senior Regulatory Affairs Specialist in Bothell, Washington
Detailed job description is attached.
Senior Regulatory Affairs Specialist
Supports business unit by providing leadership and guidance on global regulatory strategy, such as CE Marking, product registrations, and clinical evaluations.
Provides guidance on risk assessment, and required corrective actions to meet regulatory requirements, as well as
Works on issues where analysis of situations or data requires an in-depth knowledge of regulations, design controls, risk assessment processes, and organizational objectives.
Involved in developing, modifying and executing company regulatory policies that affect immediate operations.
Regularly interacts with management and cross-functional teams to provide regulatory strategy at all stages of a products lifecycle.
Mentors junior regulatory affairs members in their development.
Key Areas of Responsibility (KARs):
Responsible for product registrations/approvals.
Recommend and develop strategies and create detailed written regulatory plans 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
Worldwide product registrations
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 audit and CAPA support
Provide guidance to business unit 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 PCMS regulatory procedures and updating the procedures when new regulatory requirements become effective.
Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.
Keep abreast of current regulatory procedures and changes. Participates in direct interaction with regulatory agencies on defined matters.
Responsible for the coordination and preparation of document packages 510(k) pre-market notification and PMA applications, technical file and design dossiers for CE marking, and worldwide product registrations.
Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
May represent Philips in an international committee chartered to develop an applicable standard.
Review and approve engineering changes, advertising, promotional items and labeling for regulatory compliance.
Coordinate testing required to support regulatory submissions.
Bachelor’s degree (Master’s or Ph.D. preferred) preferably in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry.
RAPs RAC strongly preferred. ASQ certifications also desirable.
Minimum of 7-9 years of experience in the medical device industry (EU MDD, Health Canada, US FDA class II and class III, etc.).
Experience with software products preferred.
Must have personal experience with successful preparation and submission of 510(k) and/or PMA submissions.
Strong background in Design Controls.
Proficient knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws and regulations and standards including ISO14971, IEC 60601 and related particular standards.
Experience writing Clinical Evaluation Reports (CERs) that are compliant with MEDDEV 2.7.1 revision 4 highly desirable.
Knowledge of the nature and impact that the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) will have on Manufacturers and Notified Bodies.
Experience in supporting international registrations and/or clinical investigations.
Proficient computer skills in Microsoft Office.
Understand LEAN concepts, methodologies and deployment.
May require 5% travel annually with possibly some international.
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/philips-recruitment-process.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.