Regulatory Affairs Associate
Regulatory Affairs Associate
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Salary Not Disclosed
1 Vacancy
Job Description
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 pointofcare ultrasound and an industry leader in ultrahigh frequency microultrasound technology. Headquartered near Seattle the company is represented by a global distribution network in over 100 countries. Sonosites portable compact systems are expanding the use of ultrasound across the clinical spectrum by costeffectively bringing highperformance ultrasound to the point of patient care. For more information please visit www.sonosite.
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 70000 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 mediumterm 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.
For further details about our commitment to sustainability and Fujifilms 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 companys quality system.
- Must be able to maintain facility registrations as needed.
Knowledge/Experience:
- A minimum of a Bachelors degree (advanced degree or professional certification is preferred)
- A minimum of 12 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 problemsolving skills followup 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 Sonositeoffers 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 atwww.Sonosite/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 viaemail 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.
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EEO Information
Fujifilm is committedto 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 preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department or.
Required Experience:
IC
Employment Type
Unclear
