FUJIFILM
Overview
The Regulatory Affairs Associate requires application of regulatory knowledge and project management skills to oversee international registration of new products. You will work with Regulatory team members and international teams to drive systems and process improvement activities 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
At FUJIFILM Sonosite, we reinvent 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 evolving downtown—part of the vibrant Seattle metro area. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments. We are guided by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers Essential Job Functions
Author and submit regulatory technical files for international registrations, including license renewals. Work with Regulatory partners and product management to prepare regulatory schedules for Global Submissions. Collaborate with international counterparts to ensure product registrations are completed in a timely manner. 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. Responsible and accountable for carrying out the requirements of the company's quality system. Maintain facility registrations, as needed. Knowledge/Experience
A minimum of a Bachelor’s degree (advanced degree or professional certification is 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 is preferred. Skills/Abilities
Excellent analytical and writing skills. Effective interpersonal communication skills. Time and project management. Proficiency in MS Word, Adobe Acrobat and/or other PDF toolsets. Ability to work independently and under pressure (prioritize tasks, meet deadlines, strong organizational and problem-solving skills, follow-up). Attention to detail: accurate and meticulous. Salary and Benefits
$29.81/hr - $32.69/hr, depending on experience. Compensation will vary based on skills, experience and location; it is not typical to be hired at or above the top of the salary range. 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: accrue up to three (3) weeks of PTO in the first year; PTO increases with years of service. Employee Choice Holidays: Four (4) additional paid days off, based on date of hire in the calendar year. 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, check out our careers page at www.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/employment agencies will be the sole property of FUJIFILM unless an agency engagement is in place. If a candidate submitted outside of the agency engagement is hired, no fee will be paid. #CB #LI-MW EEO and ADA Information
FUJIFILM is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation, gender identity, race, ethnicity, religion, political creed, ideology, national or social origin, disability, veteran status, etc. ADA Information: If you require reasonable accommodation in completing this application, interviewing, or participating in the employee selection process, please direct your inquiries to our HR Department (ffss-hr@fujifilm.com or (425) 951-1200).
#J-18808-Ljbffr
The Regulatory Affairs Associate requires application of regulatory knowledge and project management skills to oversee international registration of new products. You will work with Regulatory team members and international teams to drive systems and process improvement activities 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
At FUJIFILM Sonosite, we reinvent 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 evolving downtown—part of the vibrant Seattle metro area. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments. We are guided by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers Essential Job Functions
Author and submit regulatory technical files for international registrations, including license renewals. Work with Regulatory partners and product management to prepare regulatory schedules for Global Submissions. Collaborate with international counterparts to ensure product registrations are completed in a timely manner. 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. Responsible and accountable for carrying out the requirements of the company's quality system. Maintain facility registrations, as needed. Knowledge/Experience
A minimum of a Bachelor’s degree (advanced degree or professional certification is 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 is preferred. Skills/Abilities
Excellent analytical and writing skills. Effective interpersonal communication skills. Time and project management. Proficiency in MS Word, Adobe Acrobat and/or other PDF toolsets. Ability to work independently and under pressure (prioritize tasks, meet deadlines, strong organizational and problem-solving skills, follow-up). Attention to detail: accurate and meticulous. Salary and Benefits
$29.81/hr - $32.69/hr, depending on experience. Compensation will vary based on skills, experience and location; it is not typical to be hired at or above the top of the salary range. 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: accrue up to three (3) weeks of PTO in the first year; PTO increases with years of service. Employee Choice Holidays: Four (4) additional paid days off, based on date of hire in the calendar year. 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, check out our careers page at www.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/employment agencies will be the sole property of FUJIFILM unless an agency engagement is in place. If a candidate submitted outside of the agency engagement is hired, no fee will be paid. #CB #LI-MW EEO and ADA Information
FUJIFILM is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation, gender identity, race, ethnicity, religion, political creed, ideology, national or social origin, disability, veteran status, etc. ADA Information: If you require reasonable accommodation in completing this application, interviewing, or participating in the employee selection process, please direct your inquiries to our HR Department (ffss-hr@fujifilm.com or (425) 951-1200).
#J-18808-Ljbffr