FUJIFILM Sonosite, Inc.
Regulatory Affairs Associate
FUJIFILM Sonosite, Inc., Bothell, Washington, United States, 98021
Overview
The Regulatory Affairs Associate requires application of regulatory knowledge and project management skills to oversee international registration for new products. The role also involves collaborating with Regulatory team members and international teams to drive systems and process improvements for integrated regulatory compliance and global submission processes, including labeling, clinical affairs, new product development, international regulatory requirements, and other areas as assigned. Company Overview
FUJIFILM Sonosite
reinvents how healthcare is delivered with point-of-care ultrasound technology. As the leader in bedside ultrasound systems, our innovations save lives—from premature babies in NICUs to trauma patients in emergency rooms. We’re looking for purpose-driven team members ready to build technology that impacts real-world scenarios, including natural disasters and even war zones. By joining FUJIFILM Sonosite, you’ll be part of a team that thrives on collaboration, out-of-the-box thinking, and a passion for life-saving innovations. Let’s make a difference together. Our headquarters in Bothell, Washington, blends riverside charm with urban amenities, quality schools, and an ever-evolving downtown—all part of the vibrant Seattle metro area. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Job Description
Essential Job Functions: Author and submit regulatory technical files for international registrations, including license renewals. Collaborate with Regulatory partners and product management to prepare regulatory schedules for global submissions. Work with international counterparts to ensure product registrations are completed in a timely manner and support legalization requests. Support R&D teams with regulatory questions and requests. Develop, implement, and train employees in regulatory processes and procedures. Maintain current, quality-system regulatory standards/guidance and product approval documents in applicable database locations that affect SonoSite Quality System standards. Ensure the company’s quality system requirements are carried out responsibly and accountably. Maintain facility registrations as needed. Knowledge/Experience
A minimum of a Bachelor’s degree (advanced degree or professional certification preferred) or a combination of work history and education. A minimum of 1–2 years of direct experience in Regulatory Affairs. The following areas of experience are highly preferred: Proven experience preparing and managing regulatory submissions. Strong knowledge and experience of Quality Management System processes, including design controls and development or documentation of procedures. Familiarity with FDA regulations and major international markets such as Canada, EU, Brazil, Japan, and Australia. Regulatory Project Management skills are required. Experience working with FDA Class II electromechanical medical devices preferred. Skills/Abilities
Excellent analytical and writing skills. Effective interpersonal communication skills. Time and project management abilities. Strong competency in MS Word, Adobe Acrobat and/or other PDF toolsets. Ability to work independently and under pressure, with strong prioritization, organization, and problem-solving skills. Attention to detail and accuracy. Salary and Benefits
Salary: $29.81/hr – $32.69/hr, depending on experience. Compensation varies based on skills, experience, and location. Insurance: Medical, Dental & Vision; Life & Company-paid Disability. Retirement Plan (401k): 4% automatic Company contribution; Fujifilm matches 50 cents for every dollar you contribute, up to 6% of salary. Paid Time Off: up to three (3) weeks of PTO in the first year, with increases based on years of service. Employee Choice Holidays: Four (4) additional paid days off, based on date of hire. Paid Holidays: Eight (8) paid holidays per year. FUJIFILM Sonosite offers a competitive compensation package, including benefits and a 401k program. To apply and obtain further details regarding key responsibilities and experience requirements, visit our careers page at Sonosite.com/about/careers. To all agencies: Please, no phone calls or emails to any FUJIFILM employee about this requisition. Resumes submitted by search firms or employment agencies will be the sole property of FUJIFILM unless engaged by FUJIFILM with a valid agreement. If a candidate submitted outside the agency engagement process is hired, no fee will be paid. EEO Information
EEO Information:
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national origin, disability, veteran status, etc. ADA Information
ADA Information:
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (ffss-hr@fujifilm.com or (425) 951-1200).
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The Regulatory Affairs Associate requires application of regulatory knowledge and project management skills to oversee international registration for new products. The role also involves collaborating with Regulatory team members and international teams to drive systems and process improvements for integrated regulatory compliance and global submission processes, including labeling, clinical affairs, new product development, international regulatory requirements, and other areas as assigned. Company Overview
FUJIFILM Sonosite
reinvents how healthcare is delivered with point-of-care ultrasound technology. As the leader in bedside ultrasound systems, our innovations save lives—from premature babies in NICUs to trauma patients in emergency rooms. We’re looking for purpose-driven team members ready to build technology that impacts real-world scenarios, including natural disasters and even war zones. By joining FUJIFILM Sonosite, you’ll be part of a team that thrives on collaboration, out-of-the-box thinking, and a passion for life-saving innovations. Let’s make a difference together. Our headquarters in Bothell, Washington, blends riverside charm with urban amenities, quality schools, and an ever-evolving downtown—all part of the vibrant Seattle metro area. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Job Description
Essential Job Functions: Author and submit regulatory technical files for international registrations, including license renewals. Collaborate with Regulatory partners and product management to prepare regulatory schedules for global submissions. Work with international counterparts to ensure product registrations are completed in a timely manner and support legalization requests. Support R&D teams with regulatory questions and requests. Develop, implement, and train employees in regulatory processes and procedures. Maintain current, quality-system regulatory standards/guidance and product approval documents in applicable database locations that affect SonoSite Quality System standards. Ensure the company’s quality system requirements are carried out responsibly and accountably. Maintain facility registrations as needed. Knowledge/Experience
A minimum of a Bachelor’s degree (advanced degree or professional certification preferred) or a combination of work history and education. A minimum of 1–2 years of direct experience in Regulatory Affairs. The following areas of experience are highly preferred: Proven experience preparing and managing regulatory submissions. Strong knowledge and experience of Quality Management System processes, including design controls and development or documentation of procedures. Familiarity with FDA regulations and major international markets such as Canada, EU, Brazil, Japan, and Australia. Regulatory Project Management skills are required. Experience working with FDA Class II electromechanical medical devices preferred. Skills/Abilities
Excellent analytical and writing skills. Effective interpersonal communication skills. Time and project management abilities. Strong competency in MS Word, Adobe Acrobat and/or other PDF toolsets. Ability to work independently and under pressure, with strong prioritization, organization, and problem-solving skills. Attention to detail and accuracy. Salary and Benefits
Salary: $29.81/hr – $32.69/hr, depending on experience. Compensation varies based on skills, experience, and location. Insurance: Medical, Dental & Vision; Life & Company-paid Disability. Retirement Plan (401k): 4% automatic Company contribution; Fujifilm matches 50 cents for every dollar you contribute, up to 6% of salary. Paid Time Off: up to three (3) weeks of PTO in the first year, with increases based on years of service. Employee Choice Holidays: Four (4) additional paid days off, based on date of hire. Paid Holidays: Eight (8) paid holidays per year. FUJIFILM Sonosite offers a competitive compensation package, including benefits and a 401k program. To apply and obtain further details regarding key responsibilities and experience requirements, visit our careers page at Sonosite.com/about/careers. To all agencies: Please, no phone calls or emails to any FUJIFILM employee about this requisition. Resumes submitted by search firms or employment agencies will be the sole property of FUJIFILM unless engaged by FUJIFILM with a valid agreement. If a candidate submitted outside the agency engagement process is hired, no fee will be paid. EEO Information
EEO Information:
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national origin, disability, veteran status, etc. ADA Information
ADA Information:
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (ffss-hr@fujifilm.com or (425) 951-1200).
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