Sr Regulatory Affairs Manager

Regulatory/Compliance | Santa Ana, CA

Job Description:

We are hiring a Sr. Regulatory Affairs Manager.  The Regulatory Affairs Manager will ensure that product, process, 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, Canadian Medical Device Regulation.  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.

Responsibilities:

  • Ensuring compliance of all processes and procedures to applicable standards.            
  • Communicating 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
  • 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:

  • Prefer B.S. or B.A. in Microbiology, Biology, or Chemistry
  • Five (5) years’ experience in Quality Assurance/Quality Control/Regulatory Affairs in a medical device discipline
  • 2+ years of supervisory experience
  • Ensure that requirements are met in all regulatory, compliance and registration functions as prescribed by the FDA’s GMPs (QSR), ISO 13485, MDD 93/42, MDR 2017/745, IVDD 98/79/EC, IVDR 2017/746, ISO 14971, Brazilian GMPs, Health Canada MDR, Australian Medical Device regulations and regulatory requirements for product registrations where products are distributed worldwide.
  • 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’s and laws.
  • Experience in Regulatory Affairs and compliance.
  • 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).
  • Ability to write, edit, speak and read english well

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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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