Sr. ROW Regulatory Affairs Specialist

Regulatory/Compliance | Santa Ana, CA

Job Function:

We are hiring a Sr. ROW Regulatory Affairs Specialist. The Sr. ROW RA Specialist 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 Files, Risk Management, FMEA, Essential Requirements, GSPR, outside references and various regulatory external and internal support as required. The person in this role will support both direct registration efforts and registration efforts made on behalf of the company by a qualified third party (i.e. Distributor). This Sr. Specialist will ensure that requirements are met in all regulatory 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, Health Canada MDR and related medical device and in vitro diagnostics requirements in all countries where product is registered and distributed.

Job Duties:

  • 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
  • Assist in the renewal and maintenance of, but not limited to, the following:
    • 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
  • Assist in the preparation and maintenance of product registrations that include, but are not limited, to the following:
    • 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
    • Registration Documents for ROW
  • Understand and implement all the regulations assigned in each country in which products are registered and distributed
    • Assist in ensuring that regulations related to in-country registration are clearly stated to ensure compliance with product registration for new or registered products
    • Assist in ensuring that distributors of FUJIFILM Irvine Scientific products are observing the regulations as mandated by regulatory authorities in-country, including that of products that are registered
  • Assist with, but not limited to, the following:
    • 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
  • Assist in the approval of, but not limited to, the following:
    • Changes to procedures
    • Product promotional material
    • Product IFUs
    • Irvine Scientific Website
  • Primary back-up to the Regulatory Affairs Manager

Experience/Education:

  • BA/BS degree preferred
  • Three or more years of direct Quality Assurance and Regulatory experience in the medical device and/or pharmaceutical industry
  • Working knowledge of GMPs, CFRs, USP, ISO 13485, CMDR, MDD 93/42/EEC, IVD D 98/79/EC, ISO harmonized standards (EN14971, EN 13408, EN 13824)
  • Ability to interpret regulatory standards, guidance and laws
  • Experience in quality 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
  • Proficient in Microsoft Word, Excel, PowerPoint, Adobe Acrobat

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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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