Fujirebio Diagnostics, Inc.
Regulatory Compliance Analyst
Monica Siegfried – Director, Regulatory Compliance
Supports Regulatory Compliance interactions with Design Control activities:
Actively participates in new product and reengineered product implementation teams.
Performs quality issuance/review of documentation for product transfers. Assesses compliance requirements for products and processes under development.
Reviews early stage manufacturing documentation for adherence to protocols and Good Documentation Practices. Completes QA Review and Release activities for new and reengineered products.
Performs review of verification/validation protocols and reports for adherence to quality system requirements.
Conducts audits of Design History Files
As needed, supports compliance assessments that are required due to changes to applicable regulations.
Supports third party inspections/audits of FDI conducted by regulatory authorities, ISO registrar and partners.
Supports Risk Management documentation review
Performs review of partner material specifications and associated revisions to Certificates of Analysis (CoA) and applicable procedures.
Follows all company environmental, health and safety policies, procedures and guidelines and conducts work in a safe manner.
Other duties as assigned.
Job Specifications (skills, knowledge, special training, certifications, license requirements)
B.A., B.S. in Life Science field
Minimum of 3 years experience in an FDA regulated industry (IVD Medical Device preferable), working in a quality or regulatory compliance function.
Working knowledge of FDA Quality System Regulations (QSR), ISO 13485 standard
Familiarity with immunoassays, antibodies/antigens, manufacturing/quality processes
Familiarity with Design Control and Risk Management concepts
Excellent written and oral communication skills required. Must be detail oriented and thorough
Excellent organizational skills and the ability to balance multiple projects and priorities
Excellent attendance required and the ability to work overtime if needed
We offer a competitive compensation and benefits package and a convenient suburban Philadelphia location.
We regret we are not able to respond to each resume received. Only those selected for an interview will be contacted.
Fujirebio Diagnostics is an Equal Employment Opportunity Employer
Fujirebio Diagnostics, Inc.
Website : http://www.fdi.com/
Fujirebio Diagnostics, Inc. is a world leader in the production of in vitro diagnostics, setting the worldwide gold standard for the manufacturing of biomarkers. Our parent company, Fujirebio, Inc., a leading healthcare company in Japan with a focus on diagnostics, acquired Fujirebio Diagnostics in 1988. In June of 2006 Fujirebio Diagnostics AB of Sweden, formerly CanAg Diagnostics, joined Fujirebio Diagnostics to strengthen the company s product offerings, distribution network, and research and development capabilities. The name Fujirebio (pronounced Fuji-Ray-Bee-Oh) symbolizes restoration of health.