Careers

Regulatory Affairs Manager

Regulatory/Compliance | Santa Ana | CA

Job Function:
We are hiring for a Regulatory Affairs Manager. The Regulatory Affairs Manager ensures that products, processes, and procedures are sufficiently controlled to assure the quality of products and compliance in accordance with GMP, ISO 13485, MDD 93/42/EEC, MDR 2017/745, IVD 98/79/EC/ IVDR 2017/746, ISO 14971, and Canadian Medical Device Regulation. In addition, this person will assist and coordinate the compiling, preparation and assembly of regulatory submission and support files for medical devices and in vitro diagnostics registration worldwide in accordance with GMP, ISO 13485, MDD 93/42/EEC, MDR 2017/745, IVD 98/79/EC, IVDR 2017/746, ISO 14971, Canadian Medical Device Regulation, and related country regulations for medical devices and in vitro diagnostics. Such activities include: Technical File creation and preparation, Risk Management, FMEA, Essential Requirements, GSPR, outside references and various regulatory external and internal support as required. The Regulatory Affairs Manager must ensure that requirements are met in all regulatory and registration functions as prescribed by the FDA’s GMPs (QSR), ISO 13485, MDD 93/42/EEC, MDR 2017/745, IVDD 98/79/EC, IVDR 2017/746, Health Canada MDR and related medical device and in vitro diagnostics requirements in all countries where product is registered and distributed.

 

Job Duties:

  • Ensure compliance of all processes and procedures to applicable standards
  • Communicate with regulatory agencies, notified bodies, and competent authorities
  • Prepare and maintain product registrations that include, but are not limited, to the following:
    • Substantial changes and new product submissions
    • Renewal of Technical Files and communication with corresponding Agents (EU AR, China, etc.)
    • US FDA 510(k) Premarket Notifications
    • US FDA Drug Master Files and annual updates
    • Technical Files for EU and EU AR
  • Oversee, manage and assist with the following activities:
    • Internal/External and Customer Audits
    • Change assessment to product design, specifications, or product manufacturing processes
    • New Product Committee (NPC) Design Control
    • Product Recalls
    • Field safety corrections
    • Mandatory Device Reporting (MDR)
    • Mandatory Problem Reporting (MPR)
    • Vigilance Reporting (EU)
    • Adverse Events Reporting (Worldwide)
    • Writing and/or revising regulatory related standard operating procedures
    • Preparing monthly reports on product registration status
    • Internal/External and Customer Audits
    • Change assessment to product design, specifications, or product manufacturing processes
    • New Product Committee (NPC) Design Control
    • Product Recalls
    • Field safety corrections
    • Mandatory Device Reporting (MDR)
    • Mandatory Problem Reporting (MPR)
    • Vigilance Reporting (EU)
    • Adverse Events Reporting (Worldwide)
    • Writing and/or revising regulatory related standard operating procedures
    • Preparing monthly reports on product registration status
  • Provide regulatory approval for the following, but not limited to:
    • Non-conformances
    • CAPA
    • Quality Planning
    • Risk Assessments
    • Document Changes (SOPs, labeling, etc.)
  • Assist in the assessment of Technical Department (R&D) activities that include, but are not limited to, the following:
    • MDR, MPR and/or vigilance investigations for complaints
    • Risk Management File Review and revision based upon complaint
  • Maintain all applicable licensing including:
    • Local, State and National Regulatory licensing and registration renewals
    • Import/Export Permits
  • Assist 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

 

Experience/Education:

  • Bachelor’s degree, preferably in Microbiology, Biology, Chemistry, or similar field
  • Five (5) years’ experience in Quality Assurance/Quality Control/Regulatory Affairs in a medical device discipline
  • 2+ years of supervisory experience
  • Thoroughly knowledgeable in requirements of GMPs, CFRs, USP, ISO 13485, CMDR, MDD 93/42/EEC, IVD D 98/79/EC
  • Knowledge of Quality Control Methodology, QA control systems and production methodologies
  • Ability to interpret regulatory standards, guidance, and laws
  • Industrial or academic experience in cell, tissues culture and/or embryology
  • Ability to obtain cooperation from other groups and lead cross functional teams
  • Experience with risk management and Failure Mode Effects Analysis (FMEA)

 

Apply Now

 

Principals only. No recruiters please.

 

FUJIFILM Irvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.

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