Regulatory Affairs Specialist at FUJIFILM Sonosite, Inc.
Bothell, WA 98021
About the Job
Employer: FUJIFILM Sonosite, Inc.
Job Title: Regulatory Affairs Specialist
Job Location: 21919 30th Dr. SE, Bothell Washington 98021
Job Duties: 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.
Requirements: 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: $90,000-$92,000/year
Contact: Please apply directly at https://www.fujifilm.com/us/en/about/region/careers
Job Title: Regulatory Affairs Specialist
Job Location: 21919 30th Dr. SE, Bothell Washington 98021
Job Duties: 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.
Requirements: 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: $90,000-$92,000/year
Contact: Please apply directly at https://www.fujifilm.com/us/en/about/region/careers
Salary
90,000 - 92,000 /year
