Regulatory Affairs Specialist

Overview

Regulatory Affairs Specialist - Bothell, WA

FUJIFILM Sonosite, Inc. If you are looking for work that matters, you’ll find it at FUJIFILM Sonosite. As the creator of point of care ultrasound, we dedicate every day to the innovation and development of imaging solutions that enable clinicians to provide improved healthcare in leading institutions, underserved populations and communities in crisis around the globe.

At FUJIFILM Sonosite, we are in the relentless pursuit of answers that allow our customers to be confident that they are making the best clinical decisions for any patient, anywhere, anytime.

Members of the FUJIFILM Sonosite team embody our company values : Go boldly, Stay curious, Passion fuels us, Respect each other, Own it and Act with integrity.

Headquartered in Bothell, WA USA, FUJIFILM Sonosite is the proud recipient of numerous prestigious design awards and has in excess of 145 patents.

Our point of care ultrasound systems are sold in more than 100 countries.

External US

Summary :

Work in medical device industry. Lead efforts in the preparation, compilation, and submission of regulatory applications for product approvals domestically and internationally.

Provide regulatory strategy and assessment for new product innovations and legacy products for US FDA and global launch.

Drive the efforts towards UKCA compliance of Sonosite products. Draft sections of DHF and work closely with project teams for development projects to provide regulatory support.

Lead the UDI requirements and review related internal policies. Review high risk complaints for regulatory reporting. Monitor Advertising and Marketing materials before launch.

Update clinical evaluation reports. Work on EU MDR requirements for cleared products. Support internal and external audits as necessary.

Implement post-market activities, such as supporting technical file preparation, review and approval of regulatory design inputs and outputs.

Participate in regulatory and quality related non-conformities, corrections, corrective and preventive actions. Assess internal SOPs, design documents, and reports.

Utilize Quality Management Systems for medical device product development. Use Medical device design Controls Regulations including 21 CFR 820 quality system regulation.

Employ Nonconforming Product and Corrective and Preventive Actions per 21 CFR 820; and employ FDA, EU and global regulations and standards including 21 CFR 820, FDA 510(k) submissions, EU MDR, Health Canada device license amendments, and ISO 13485 for medical device development and compliance

Knowledge and Experience :

• Master’s Degree in Biomedical Regulatory Affairs, Biotechnology, or a related field and one (1) year of experience in position offered or related position including one (1) year of experience working in a medical device industry
• Assessing internal SOPs, design documents, and reports; utilizing Quality Management Systems for medical device product development;

using Medical device design Controls Regulations including 21 CFR 820 quality system regulation

employing Nonconforming Product and Corrective and Preventive Actions per 21 CFR 820; and employing FDA, EU and global regulations and standards including 21 CFR 820, FDA 510(k) submissions, EU MDR, Health Canada device license amendments, and ISO 13485 for medical device development and compliance

Salary and Benefits :

• $90,000- $92,000 + variable bonus opportunity
• 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.