Senior Regulatory Affairs Specialist - Remote
Full Job Description
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.
This position is intended to provide Regulatory Affairs expertise and support to all FUJIFILM Healthcare Americas Corporation (HCUS) business sites. 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. This position also provides guidance, training and support to other HCUS Regulatory Affairs Specialists.
Duties and Responsibilities
- Provide guidance, training and support to other FMSU Regulatory Affairs Specialists.
- Coordinate and complete U.S. FDA pre-market submissions (510(k) and PMA) in accordance with the FMSU business plan.
- Provide U.S. FDA pre-market submission guidance, feedback and recommendations to FMSU and FTYO business teams.
- Maintain the U.S. FDA database for Establishment Registrations and Device Listings for all FUJIFILM business entities.
- Maintain the FMSU Unique Device Identifier database.
- Ensure all required FMSU U.S. State Registrations are obtained and maintained.
- Prepare European Union Technical Files and International Regulatory Submissions.
- Provide support for International Registrations, as needed.
- Coordinate U.S. Import/Export/Customs related activities.
- Determine the Medical Device Reportability and Accidental Radiation Occurrence assessment of all identified Customer Complaints, take appropriate action and maintain all records.
- Coordinate Mandatory Field Notifications, Engineering Change Orders, and Field Actions, 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.
- Support and provide evidence for Internal Audits and External Audits.
- Coordinate and prepare documentation for remediation activities.
- Prepare Key Performance Indicator reports and data for Management Review Meeting presentations.
- Perform Labeling Review for all product lines.
- Create and/or update Standard Operating Procedures and Work Instructions.
- Attend all department and company-wide team meetings as needed.
- May be appointed as a delegate for regulatory affairs activities.
- 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.
- Bachelor Degree highly preferred.
- Three (3) or more years of hands on experience performing Regulatory Affairs support activities in a U.S. FDA regulated environment.
- Deep 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.
- Deep 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.
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.
- Occasional (up to 25%) travel may be required based on business need.
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.
If COVID-19 vaccine is mandated by the federal government, or by state or local government, the Company will require that the successful candidate hired for positions covered under relevant government vaccine mandate(s) be fully vaccinated against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption. For all positions, the Company encourages vaccination against COVID-19 and may require that the successful candidate hired be willing to test for the COVID-19 virus periodically and wear a face covering indoors absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption.
Job Type: Full-time
Pay: $95,000.00 - $100,000.00 per year
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Retirement plan
- Tuition reimbursement
- Vision insurance
- Day shift
- Monday to Friday
Supplemental pay types:
- Bonus pay
Work Location: Remote
Your application has been successfully submitted.