Senior Regulatory Operations Specialist

Job Summary:

The Sr. Regulatory Operations Specialist will be responsible for providing regulatory compliance guidance to product development, quality assurance and operations teams. This role will include regulatory impact analysis of design and manufacturing changes, UDI submissions for US and international markets and CAPA assessments for non-conforming process/product.  The Sr. Regulatory Operations Specialist will work closely with product management and operations team members to ensure regulatory listings and lifecycle status of devices are updated and accurate. The role will also be responsible for reviewing general RA requests and forwarding questions to appropriate specialist within the RA/QA department.

Essential Job Functions:

• Provide regulatory assessment of product changes in collaboration with other regulatory specialists to assess impact of changes to global market registrations. Documentation of impact assessment for each country with appropriate submission decision rationale.
• Support quality, value and sustaining projects with Regulatory Compliance review of change requests and identified hardware or software defects.
• Support Regulatory compliance projects, including CAPAs and HHE/HRA on an as needed basis.
• Work alongside FUJIFILM SonoSite international partners on local regulations for initiating and following up on Recalls.
• Participate in creation, deployment and maintenance of Regulatory procedures
• Participate in decision-making process for IT system enhancements or new software support implementation within the regulatory affairs department.
• Serve as the regulatory point of contact for Sales Operations, Manufacturing Operations and Supply Chain
• Support submission planning and prioritization with Regulatory team management and will be responsible for driving regulatory compliance projects to closure.

Knowledge and Experience:

• Bachelor’s Degree in a relevant field. A Master's Degree is preferred
• A minimum of 6-8 year’s experience, with 3-5 years of experience in medical device industry with experience working with design and operations teams.
• Quality Systems training or certification (preferred)
• Experience with document management and publishing software, including UDI coordination/publishing software
• Excellent written and verbal communication
• Effective project management skills
• Solid understanding of and experience in Design Controls and change impact analysis
• Experience working with global regulatory partners
• Working knowledge of Post-Market activities, including global regulatory requirements
• Experience in reviewing and performing data analysis with large databases (such as Product Lifecycle Management suites, review of Bill of Materials, and Country Registration Listings)
• Experience in Regulatory Change Impact Assessments for pre-market submissions.

FUJIFILM SonoSite, Inc.  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/careers.

FUJIFILM SonoSite, Inc.   is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age, protected veteran status, disability status, or any other characteristic protected by law. 

In compliance with the ADA Amendments Act, should you have a disability that requires assistance and / or reasonable accommodation with the job application process, please contact the Human Resources department via phone at 425-951-1200, or via e-mail at ffss-hr@fujifilm.com .   Additionally, the affirmative program/plan is available for review upon formal request by employees and applicants for employment in the Human Resources office during regular office hours