Senior Regulatory Affairs Specialist - 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.
The Sr. Regulatory Affairs Specialist is a critical link between FUJIFILM SonoSite's product development team and regulatory authorities. Sr. RA Specialists combine their knowledge of scientific, regulatory, and business practices to ensure FUJIFILM SonoSite is in compliance with the current regulations surrounding marketing, labeling, and legal issues in order to control the marketability of our products globally.
This position will be responsible for providing regulatory affairs leadership, as well as coordinating and executing Class II regulatory submissions to various international regulatory agencies, including FDA (510(k)), Health Canada, European Union (CE mark), TGA (Australia), New Zealand (Medsafe), ANVISA (Brazil), CFDA (China), PAL 3rd Party (Japan), and others, TBD. In this role you will work under tight timelines with the regulatory team while maintaining communication with product managers, engineers and RA management.
Essential Job Functions:
Evaluate proposed product modifications for Regulatory impact on a global markets, completing Regulatory Impact Assessments as needed.
Participate in communicating to upper management the impact of new regulatory requirements or changes to existing requirements.
Provide guidance to team members (RA team or Design team) on regulatory requirements (including safety/performance standards) for specific products.
Coordinate and prepare product submission packages for regulatory agencies (U.S. and major International markets).
Development strategies by conducting research on submission requirements and options.
Liaise with engineering project managers, distributors, subsidiaries and regulatory agencies.
Respond to information requests from competent authorities.
Stay abreast of regulatory procedures and changes in the global regulatory climate.
Maintain records on legislation, relations and guidelines.
Assist in monitoring and reporting project timelines.
Maintain paper and electronic regulatory files.
Investigate regulatory history of similar products to assess approval implications.
Perform tasks associated with assigned development core teams to provide regulatory guidance.
Knowledge and Experience:
Requires a Bachelor's degree with ~ 8 years of related experience in regulatory affairs; or a specialize RA degree with ~5 years regulatory affairs experience
Experience with regulatory submissions for software as a medical device
Extensive knowledge and experience in design validation and verification processes
Knowledge of Risk Management Standard ISO 14971.
Extensive experience with U.S. FDA and major international market regulations (Canada, EU, Brazil, Japan, Australia, etc.)
Regulatory Project Management skills
Preferred: Experience with U.S FDA Class II (electromechanical) devices
Skills and Abilities:
Ability to work independently and under pressure (able to prioritize tasks, deadline oriented, good organizational and problem-solving skills, follow-up skills).
Ability and willingness to mentor other team members
Excellent analytical and writing skills
Effective interpersonal communication skills
Excellent time, task and project management
Superior Competency in MS Word, Adobe Acrobat and/or other PDF toolset.
Committed attention to detail: accurate and meticulous.
FUJIFILM SonoSite, Inc. offers 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 email@example.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.