Regulatory Affairs Specialist



Duration: 12 mo, Contract, W-2


Pay: $39.22 - 45.95/hr


Onsite in Irvine, CA






Completes and maintains regulatory approvals and clearances of medical device products.


Sustaining the Regulatory Affairs lifecycle management team






Job Description



• Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements. Present alternatives for meeting regulatory requirements and resolve conflicts between those requirements and development issues, and/or reporting to management.


• Prepare and oversee documentation packages for submission to global regulatory agencies. Track timelines and documents milestone achievements for inclusion in regulatory submissions.


• May interact with regulatory agencies as part of submission review and on-site audit support (e.g., US FDA, EU notified bodies, Japan PMDA, Australia TGA, Japan PMDA, other global regulatory agencies, submissions, dossiers and technical files)


• Provide guidance on regulatory requirements necessary for contingency planning



• Monitor proposed and current global regulations and guidance; assesses impact of such regulations and guidance on assigned project(s); proposes suggestions on utilizing regulatory updates to expedite approval process


• Review labeling content, product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy


• Prepare documents for submissions to global regulatory bodies.


Qualifications & Experience:



• Bachelor's Degree in scientific discipline (e.g., Biology, Microbiology, Chemistry)


• 2-4 years of experience with commercial class III and class II medical devices and EU MDR preferred


• Experience registering products and renewing licenses



• Manufacturing experience (specifically OUS transfer solutions and other change requests)


• Experience supporting audits by the FDA or EU & Compliance initiatives (meeting new regulations or meeting annual reporting requirements)


• Coursework, seminars, and/or other formal government and/or trade association training required


• Proven expertise in Microsoft Office, Adobe.


• Experience in PLM systems (Agile, Teamcenter etc.) & Labeling Software preferred


All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. To the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.