Sr. Regulatory Affairs Spec

Responsibilities

• Responsible in the renewal and maintenance of, but not limited to, the following : Local, State and National Regulatory licensing and registration renewals
• Import/Export Permits
• Aid in the identification of, but not limited to, the following: Relevant guidance documents, international standards, or consensus standards and their interpretation as they relate to registration requirements
• Notification to management of new and revised documents referenced above
• Aid in the preparation and maintenance of Drug Master Files that include, but are not limited, to the following: US FDA Health Canada Japan PMDA
• Ensure compliance of all processes and procedures to applicable standards
• Have knowledge of product line requirements worldwide including for Ancillary Materials and Therapies supported by FISI
• Communicate with regulatory agencies, notified bodies, and competent authorities
• Perform the following activities: Write and/or revise standard operating procedures
• Review and approval of scientific data generated to support claims, warnings and precaution of products
• Review promotional items and frequently asked questions (FAQ) and answers
• Support Internal/External and Customer Audits
• As needed assist with changes to product design, specifications, or product manufacturing processes
• Member of the New Product Design Control
• Aid in Product Recalls
• Aid in the approval of, but not limited to, the following: Non-conformances CAPA Quality Planning Risk Assessments Document Changes (SOPs, labeling, etc.)
• Support customers with their regulatory filings and provide technical support as needed
• Aid in the assessment of Technical Department (R&D) activities that include, but not limited to, the following: Risk Management File Review and revision based upon complaint Primary back-up to the Senior Manager of Regulatory Affairs

Qualifications

• B.S. or B.A.
• Three to Five years of direct Quality Assurance and Regulatory experience in the medical device and/or pharmaceutical industry.
• GMPs, CFRs, USP, ISO 13485Quality control methodology, QA controls systems and production methodologies.
• Experience in cell, tissues culture and/or embryology.
• Experience can be from education or industry.
• Ability to obtain cooperation from other groups and lead cross functional teams.
• Experience with risk management and Failure Mode Effects Analysis (FMEA).
• Understanding of validation of processes and equipment, methods validations, process investigations, technical evaluation.
• Regulatory Affairs Certificate preferred
• Proficient in Microsoft Word, Excel, PowerPoint, Adobe Acrobat.
• Ability to write, edit, speak and read English well.