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 atwww.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 firstname.lastname@example.org. 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
Internal Number: 2020-13133
About FUJIFILM Sonosite Inc.
FUJIFILM, SonoSite, Inc . We are an innovative and high performance culture with tremendous opportunities. People who work here are given the unique opportunity to contribute to the advancement of healthcare throughout the world. Headquartered in Bothell, WA USA, FUJIFILM SonoSite is represented by a global distribution network in over 100 countries. Since its inception, FUJIFILM SonoSite’s lightweight, robust products have created and led the point-of-care ultrasound market. From sophisticated urban hospital emergency rooms to clinics in austere, remote villages, FUJIFILM SonoSite systems are used by over 21 medical specialties and provide clinicians around the world with a cost-effective tool for improving patient safety and workflow efficiency. FUJIFILM SonoSite holds a number of prestigious design awards and has in excess of 145 patents.