Regulatory Program Administrator
Company: FUJIFILM Diosynth Biotechnologies
Posted on: June 13, 2021
FUJIFILM Medical Systems U.S.A., Inc. is a leading provider of
unrivaled diagnostic imaging products and medical informatics
solutions that meet the evolving needs of healthcare facilities
today and into the future. Medical imaging solutions span digital
radiography (DR), detectors, portables and suites, mammography
systems with digital breast tomosynthesis, computed tomography
solutions for oncology and radiology applications, as well as
technologically advanced flexible and surgical endoscopy solutions.
Fujifilm enables interoperability through its Systems Integration
offering as well as its comprehensive, AI-supported Synapse
Enterprise Imaging portfolio, which includes the TeraMedica
Division of Fujifilm. FUJIFILM Medical Systems U.S.A., Inc. is
headquartered in Lexington, Massachusetts. For more information
please visit www.fujifilmhealthcare.com.
Job purposeThis position is intended to provide executive level
support to the FUJIFILM Medical Systems U.S.A., Inc. (FMSU) Vice
President of Regulatory and Quality Affairs and to the FMSU
Regulatory and Quality Affairs team at all FMSU business sites.
This position is intended to execute FMSU Regulatory and Quality
Affairs duties and to facilitate department coordination and
cohesion at all FMSU business sites.
Duties and responsibilities
- Manage the FMSU Regulatory and Quality Affairs Department
budget. Identify areas of cost savings and expense reduction.
Implement expense controls when required. Collaborate closely with
the FMSU Finance team on annual budget creation and any
re-budgeting adjustments. Ensure department invoices are approved
and paid in a timely manner.
- Actively participate as a key member of the FMSU Product Safety
- Actively participate in and help to coordinate all FMSU United
States Food and Drug (U.S. FDA) Inspections and all Notified Body
- Oversee FMSU Regulatory and Quality Affairs Department
operational process improvements and efficiency, encourage teamwork
and collaboration, process harmonization and optimization.
- Coordinate the completion and the reporting of the Monthly FMSU
Regulatory and Quality Affairs Department Key Performance
- Coordinate executive travel arrangements and expense
- Maintain the FMSU Regulatory and Quality Affairs team
- Maintain the FMSU Regulatory and Quality Affairs organizational
chart and help drive department recruitment efforts to successful
- Coordinate FMSU Regulatory and Quality Affairs Department
meetings, interdepartmental meetings, FMSU/FUJIFILM Corporation
business meetings and other external business meetings as
- Review FMSU Regulatory and Quality Affairs Department expense
reports and staff time off requests.
- 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's Degree required.
- Three (3) or more years of experience performing Regulatory and
Quality Affairs support activities in a U.S. FDA regulated
- 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
- Excellent organizational skills with an ability to think
proactively and prioritize work.
- Physical requirementsThe position requires the ability to
perform the following physical demands and/or havethe listed
- 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
- The ability to stand, talk, and hear for 75% of applicable work
- 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
TRAVEL:Occasional (up to 25%) travel may be required based on
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
Keywords: FUJIFILM Diosynth Biotechnologies, Boston , Regulatory Program Administrator, Other , Lexington, Massachusetts
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