What are the responsibilities and job description for the Regulatory Affairs Associate position at FFSS- FUJIFILM Sonosite?

Position Overview

Regulatory Affairs Associate - Bothell, WA

The Regulatory Affairs Associate requires application of regulatory knowledge and project management skills to oversee international registration of new products. As the 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

FUJIFILM Sonosite, Inc. is the innovator and world leader in bedside and point-of-care ultrasound, and an industry leader in ultra-high frequency micro-ultrasound technology. Headquartered near Seattle, the company is represented by a global distribution network in over 100 countries. Sonosite’s portable, compact systems are expanding the use of ultrasound across the clinical spectrum by cost-effectively bringing high-performance ultrasound to the point of patient care. For more information, please visit

www.sonosite.com

FUJIFILM Corporation is a subsidiary of FUJIFILM Holdings Corporation. FUJIFILM Holdings Corporation, headquartered in Tokyo, leverages its depth of knowledge and proprietary core technologies to deliver innovative products and services across the globe through the four key business segments of healthcare, electronics, business innovation, and imaging with over 70,000 employees. Guided and united by our Group Purpose of “giving our world more smiles,” we address social challenges and create a positive impact on society through our products, services, and business operations. Under its medium-term management plan, VISION2030, which ends in FY2030, we aspire to continue our evolution into a company that creates value and smiles for various stakeholders as a collection of global leading businesses and achieve a global revenue of 4 trillion yen (29 billion USD at an exchange rate of 140 JPY / USD). For more information, please visit :

www.fujifilmholdings.com

For further details about our commitment to sustainability and Fujifilm’s Sustainable Value Plan 2030,

click here

Job Description

Essential Job Functions :

Author and submit regulatory technical files for international registrations.
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.
Assists, as necessary, with oversight of clinical trials / studies, including selection criteria and regulatory input. Other duties include, but are not limited to assisting with IRB submissions, site monitoring and selection, site reports / closures, tracking of ongoing clinical studies, and reports required for clinical trial / study documentation.
Develop, implement and train employees on 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 :

A minimum of a Bachelor’s degree (advanced degree or professional certification is preferred)

A minimum of 1-2 years of direct experience in Regulatory Affairs

The following areas of experience are highly preferred :

Experienced in regulatory submissions

Strong knowledge and experience of Quality Management System processes, include design controls

Experience with FDA and major international market regulations (Canada, EU, Brazil, Japan, Australia, etc.) is preferred

Regulatory Project Management skills is required

Experience with FDA Class II (electromechanical) devices preferred

Skills / Abilities :

Excellent analytical and writing skills

Effective interpersonal communication skills

Time and project management

Superior Competency in MS Word, Adobe Acrobat and / or other PDF toolset.

Ability to work independently and under pressure (able to prioritize tasks, deadline oriented, good organizational and problem-solving skills, follow-up skills).

Committed attention to detail : accurate and meticulous.

Salary and Benefits :

29.00 / hr - 34.00 / 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 your salary

Paid Time Off :

You can accrue up to three (3) weeks of PTO in your first year of employment

PTO increases based on 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 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 / about / careers

To all agencies : Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms / employment agencies to any employee at FUJIFILM via-email, the internet or in any form and / or method will be deemed the sole property of FUJIFILM, unless such search firms / employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

LI-MW

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

425) 951-1200

Salary : $29

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