Regulatory | Santa Ana | CA
We are seeking an individual to 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 and activities include: Technical Files, Risk Management, FMEA, Essential Requirements, outside references and various regulatory external and internal support as required.
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 China and ROW
Understanding, implementation of all the regulations assigned in each country in which products are registered and distributed.
- Assisting in insuring that regulations related to in-country registration is to clearly stated to ensure compliance with product registration for new or registered products
- Assisting in ensuring that distributors of IS 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 Senior Regulatory Affairs Manager
- 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).
- 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.
- Ability to write, edit, speak and read English well.
To Apply: Please send resume to: firstname.lastname@example.org. Please put Regulatory Specialist 010319 in the subject line.
Principals only. No recruiters please.
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.