Regulatory Affairs Specialist – FDA Medical Device Regulation

This is a fully remote position, open to applicants in United States.

📋 Description

• Offer Regulatory Affairs assistance to FUJIFILM Healthcare Americas Corporation

• Ensure ongoing compliance with U.S. FDA medical device regulatory standards, relevant ISO 13485 requirements, and other pertinent laws, regulations, and standards

• Act as Designated Responsible Personnel for device marketing authorization and facility registration, encompassing registration, listing, licensing, notification, and approval submissions

• Engage with a regulatory authority or authorized representative in the Medical Device Single Audit Program (MDSAP)

• Function as Designated Joint Responsibility in accordance with Article 15 of the EU MDR

• Execute pre-market U.S. FDA submissions, including 510(k) and PMA, following the product strategy

• Counsel design teams on the appropriate timing for submitting a 510(k) for modifications to existing medical devices

• Convey regulatory documentation findings for new products and supplier evaluations to business units

• Compile EU technical documentation and international regulatory submissions

• Assess incoming customer information, probe and document escalated customer grievances, conduct trend analysis, and maintain records

• Validate medical device reportability of potential adverse events and take necessary action

• Manage field action notifications, risk assessments, and corrections and removals

• Collaborate with Customer Service, Service, Repair, R&D, Quality Assurance, Regulatory Affairs, and Sales

• Carry out Corrective and Preventive Action activities

• Prepare QMS audit data and remediation documentation

• Assist with import/export/customs processes

• Gather data for Management Review Meetings

• Participate in department and company-wide meetings as required

• Undertake additional responsibilities as assigned

⛳️ Requirements

• Bachelor's degree in a related field and a minimum of 2 years of practical experience in Regulatory Affairs support activities within a U.S. FDA regulated environment OR Regulatory Affairs Certification with 4+ years of practical experience in such an environment

• Comprehensive understanding of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807)

• Familiarity with U.S. FDA import/export/customs regulations

• Extensive knowledge of international medical device standard requirements (ISO 13485/ISO 9001, ISO 14971, EU Medical Device Directive, and Canada Medical Device Regulations)

• Exceptional leadership, communication, collaboration, teamwork, and interpersonal skills

• Ability to effectively engage with staff members and business partners across all organizational levels, both internal and external

• Proficient computer and internet research skills

• Strong capability to multitask and adhere to business deadlines

• Excellent organizational skills with the ability to think proactively and prioritize tasks

• Capability to sit for 75-100% of the applicable work time

• Ability to use hands and fingers to feel and manipulate items, including keyboards, for up to 100% of the applicable work time

• Ability to stand, speak, and hear for 75% of the applicable work time

• Capacity to lift and carry up to ten pounds for up to 20% of the applicable work time

• Close Vision: ability to see clearly at twenty inches or less

• Occasional travel of up to 25% may be necessary

• Willingness to adhere to applicable COVID-19 testing, face covering, vaccination, and facility credentialing requirements when necessary

🏝️ Benefits

• 8% Bonus opportunity

• Medical

• Dental

• Vision

• Life Insurance

• 401k

• Paid Time Off

• Flexible environment

• Reasonable accommodation in the application and selection process