Regulatory Affairs Specialist

Overview:

FUJIFILM Healthcare Americas Corporation is a leading innovator in diagnostic and enterprise imaging solutions designed to meet the evolving needs of healthcare across prevention, diagnosis, and treatment. Fujifilm’s medical imaging portfolio includes solutions for digital radiography, mammography, computed tomography, magnetic resonance imaging, ultrasound, endoscopy, and endosurgery. The Synapse® Enterprise Imaging portfolio provides healthcare professionals with the imaging and data access needed to deliver a complete patient record. REiLI®, Fujifilm’s artificial intelligence initiative, combines Fujifilm’s rich image -processing heritage with cutting-edge AI innovations to inspire a new tier of clinical confidence. The In-Vitro Diagnostic portfolio provides the golden standard of molecular based immunoassay technology for liver surveillance, cutting edge clinical diagnostic chemicals for leading laboratories across the country and diagnostic chemicals for OEM white labeling products. The company is headquartered in Lexington, Massachusetts. For more information, please visit healthcaresolutions-us.fujifilm.com.

Job Title: Regulatory Affairs Specialist

Job purpose

This position is intended to provide Regulatory Affairs support to FUJIFILM Healthcare Americas Corporation. This position supports full, ongoing compliance to all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations, and standards.

Duties and responsibilities

• Designated Responsible Personnel for Device Marketing Authorization and Facility Registration to include proper registration, listing, licensing, notification and approval information submission to regulatory authorities or authorized representative participating in the Medical Device Single Audit Program (MDSAP) (ISO 13485/MDSAP)
• Designated Joint Responsibility pursuant of Article 15 of the European Union Medical Device Regulation (EU MDR (EU) No. 2017/745)
• Perform Pre-Market U.S. FDA submissions (510(k) and PMA) in accordance with the product plan.
• Provide feedback and recommendations to design teams regarding deciding when to submit a 510(k) for a change to an existing medical device.
• Prepare European Union Technical Files and International Regulatory Submissions.
• Coordinate Import/Export/Customs activities.
• Evaluate all sources of incoming customer information, identify, investigate, and document Customer Complaints, perform trend analysis and maintain all records.
• Determine the Medical Device Reportability of all identified Customer Complaints, take appropriate action and maintain all records.
• Coordinate all Mandatory Field Notifications, Engineering Change Orders, and Correction and Removals, take appropriate action and maintain all records.
• Interact closely with Customer Service, Service, Repair, Research and Development, Quality Assurance, Regulatory Affairs and Sales to facilitate required action.
• Perform Corrective and Preventive Action activities.
• Prepare documentation for remediation activities.
• Prepare Management Review Meeting presentations.
• Attend all department and company-wide team meetings as needed.
• Other duties as assigned.
• Comply with all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations, and standards.

Qualifications 

• Bachelor’s degree highly preferred.
• Three (3) or more years of hands-on experience performing Regulatory Affairs support activities in a U.S. FDA regulated environment.
• Broad knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807) and U.S. FDA import/export/customs regulations.
• Broad knowledge of international medical device standard requirements (ISO 13485/ISO 9001, ISO 14971, EU Medical Device Directive and Canada Medical Device Regulations).
• Excellent leadership, communication, collaboration, team work and interpersonal skills.
• Superb ability to effectively communicate with staff members and business partners at all levels of the organization (both internal and external).
• Excellent computer and internet search skills.
• Strong ability to multi-task and to meet business deadlines.
• Excellent organizational skills with an ability to think proactively and prioritize work.

Physical requirements

The position requires the ability to perform the following physical demands and/or have the listed capabilities:

• The ability to sit up 75-100% of applicable work time.
• The ability to use your hands and fingers to feel and manipulate items, including keyboards, up to 100% of applicable work time.
• The ability to stand, talk, and hear for 75% of applicable work time.
• The ability to lift and carry up to ten pounds up to 20% of applicable work time.
• Close Vision: The ability to see clearly at twenty inches or less.

Travel

• Occasional (up to 25%) travel may be required based on business need.

Equal Opportunity Employer

FUJIFILM is an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.