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Sr. Regulatory Affairs Specialist

Company Name: Fujifilm Irvine Scientific
Location: Santa Ana, CA
Job Type: Full-Time/Exempt
Contact Name: P.J. Marcus
Email: (Apply Directly Online - See Below)
Salary: Depending upon experience

Job Description (up to 200 words):

Irvine Scientific, a member of Fujifilm Holdings Corporation, is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. 

We are hiring for a Sr. Regulatory Affairs Specialist. The Sr. 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, IVD D 98/79/EC, 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, outside references and various regulatory external and internal support as required. In addition, the Sr. RA Specialist will support both direct registration efforts and registration efforts made on behalf of the company by a qualified third party (i.e. Distributor). This person will also ensure that requirements are met in all regulatory and registration functions as prescribed by the FDA’s GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC, Health Canada MDR and related medical device and in vitro diagnostics requirements in all countries where product is registered and distributed.

Job Requirements (up to 200 words): 

  • Assist in the assessment of Technical Department (R&D) activities
  • Assist in the renewal and maintenance of regulatory licensing and registration renewals
  • Assist in the identification of relevant guidance documents, international standards, or consensus standards and their interpretation as they relate to registration requirements
  • Assist in the preparation and maintenance of product registrations
  • Understanding and implementation of all the regulations assigned in each country in which products are registered and distributed
  • Perform other duties and tasks as assigned 

Experience/ Education:

  • B.S. or B.A. preferred. 
  • Five or more years of direct Quality Assurance and Regulatory experience in the medical device and/or pharmaceutical industry
  • 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
  • Quality control methodology, QA controls systems and production methodologies
  • Experience in cell, tissues culture and/or embryology (Experience can be from education or industry)
  • 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 

For a complete job description and to review the requirements please visit: iis=OCRA