Regulatory Affairs Associate

Regulatory Affairs Associate

The Regulatory Affairs Associate requires application of regulatory knowledge and project management skills to oversee international registration new products. As a Regulatory Affairs Associate you will also work with Regulatory team members & international teams to drive systems & process improvement activities for integrated regulatory compliance and global submission processes, including labelling, 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 livesfrom 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 downtownall 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.
• Work with Regulatory partners and product management to prepare regulatory schedule for Global Submissions
• Works with international counterparts to ensure product registrations are completed in a timely manner. Support legalization requests.
• Support R&D team 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.
• Must be able to maintain facility registrations, as needed.

Knowledge / Experience :

The following areas of experience are highly preferred :

Skills / Abilities :

Salary and Benefits :

FUJIFILM Sonosite 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.

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, or social origin, disability, veteran status, etc.

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).