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Senior Regulatory Compliance Engineer

Senior Regulatory Compliance Engineer

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Senior Regulatory Compliance Engineer - Bothell, WA


FUJIFILM, SonoSite, Inc . We are an innovative and high performance culture with tremendous opportunities.  People who work here are given the unique opportunity to contribute to the advancement of healthcare throughout the world.  Headquartered in Bothell, WA USA, FUJIFILM SonoSite is represented by a global distribution network in over 100 countries.  Since its inception, FUJIFILM SonoSite’s lightweight, robust products have created and led the point-of-care ultrasound market. From sophisticated urban hospital emergency rooms to clinics in austere, remote villages, FUJIFILM SonoSite systems are used by over 21 medical specialties and provide clinicians around the world with a cost-effective tool for improving patient safety and workflow efficiency. FUJIFILM SonoSite holds a number of prestigious design awards and has in excess of 145 patents.


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Job Summary:


The Senior Regulatory Compliance Engineer will be a key contributor to compliance activities within the Regulatory Affairs group at FUJIFILM SonoSite. This individual will work closely with product development teams, across all product platforms.  Additionally, the Sr. Standards Compliance and Regulatory Specialist will work with foreign and domestic partners on region (or country) specific requirements and address accordingly.


Essential Job Functions:


  • Review product requirements to determine standards applicability (U.S. & International) for regulatory planning purposes;
  • Maintain external standards database/documentation;
  • Develop and maintain Technical Documentation Files and checklists (for EU, Australia/New Zealand and Russia);
  • Assist with the development and maintenance of Radio Equipment Directive (RED, 2014/53/EC), and RoHS Technical Files;
  • Support product development project teams to ensure regulatory/standards requirements are identified and met throughout the development process;
  • Monitor the applicability of foreign safety standards (i.e. EU, China, Japan, Russia, Brazil) in addition to IEC, ISO, ANSI, etc. and communicate impacts to appropriate teams;
  • Review changes to existing products and SOPs to define the requirements for regulatory submissions;
  • Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products (Class II (US), IIa (EU) and III (Canada);
  • Actively participate in evaluation of regulatory compliance of document / product / process / test method(s) changes;
  • Participate in research of regulatory issues and dissemination regulatory information to Production, QA and R&D departments and senior management as required;
  • Assist the regulatory team, as needed, with worldwide regulatory submissions;
  • Assist the regulatory team with gathering and documenting regulatory intelligence;
  • Facilitate testing (i.e. biocompatibility, wireless certifications, etc.), as needed, under the guidance of RA management;
  • Other duties as assigned;


Knowledge and Experience:


  • Bachelor’s degree (B.S. or B.A.) required, preferably in engineering or life sciences.
  • Regulatory affairs or compliance engineering experience in the Medical Device industry is preferred [minimum 5 years].
  • Familiarity with IEC standards for Medical Devices: IEC 60601, 60601-2-37, 62304, other CE Mark requirements such as Technical Documentation Files and ISO 14971.
  • Experience at formulating successful regulatory/compliance strategies that meet aggressive preparation and approval timelines
  • Ability to work in small team environment; team based work environment experience preferred
  • Experience with electromechanical devices desired


Skills and Abilities:


  • Must be able to communicate effectively (verbal and written)
  • Proficient in Microsoft Office (Word, Excel or Access, PowerPoint)
  • Capable of meeting aggressive deadlines and be detailed orientated. Good planning and organization skills a must.
  • Strong critical thinking and problem solving skills.
  • Ability to learn quickly in a fast-paced work environment.



FUJIFILM SonoSite, Incoffers a fantastic compensation package, including benefits, and a 401k program.  Visit us today to learn more about our exciting technologies and how you can make a difference.  To apply and obtain further details regarding key responsibilities and experience requirements, check out our careers page at   www.SonoSite.com/careers.

FUJIFILM SonoSite, Inc.   is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age, protected veteran status, disability status, or any other characteristic protected by law. 

In compliance with the ADA Amendments Act, should you have a disability that requires assistance and / or reasonable accommodation with the job application process, please contact the Human Resources department via phone at 425-951-1200, or via e-mail at ffss-hr@fujifilm.com .   Additionally, the affirmative program/plan is available for review upon formal request by employees and applicants for employment in the Human Resources office during regular office hours.