Regulatory Affairs Specialist
Regulatory Affairs Specialist
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Salary Not Disclosed
1 Vacancy
Job Description
Job Title: Regulatory Affairs Specialist (RA Specialist)
Location: Orange County CA (Hybrid)
Pay Rate: $38.46/hr $45.67/hr
Contract: 6-month contract assignment with potential to be longer
A recognized global leader in Assisted Reproductive Technology (ART) is seeking an experienced Regulatory Affairs Specialist for a 6-month contract assignment. The ideal candidate will have direct experience with international regulatory standards governing medical devices and in vitro diagnostics (IVDs) including GMP ISO 13485 MDR 2017/745 MDD IVDD ISO 14971 and CMDR.
Key Responsibilities:
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Manage and maintain international product registrations (EU China ROW).
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Support preparation and submission of US FDA 510(k)s EU Technical Files and other global filings.
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Update Technical Files and RA/CA SOPs to reflect regulatory and organizational changes.
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Monitor compliance with country-specific registration and distribution regulations.
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Review and interpret relevant standards guidance documents and regulations.
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Support internal/external audits design changes and field actions (e.g. recalls adverse event reporting).
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Collaborate cross-functionally to ensure global regulatory compliance.
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Prepare regular reports on registration status and regulatory activity.
Qualifications:
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3 5 years of Regulatory Affairs and/or Quality Assurance experience in medical device or pharmaceutical industries.
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In-depth knowledge of global regulatory requirements (e.g. GMP ISO 13485 CFRs etc..
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Direct experience with risk management (FMEA) process validation and QA practices.
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Familiarity with cell and tissue culture or embryology is preferred (industry or academic).
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Proficiency in Microsoft Word Excel PowerPoint and Adobe Acrobat.
Employment Type
Full Time
