REGULATORY AFFAIRS SPECIALIST
Gish Biomedical Inc, is currently seeking a Regulatory Affairs Specialist. This position will be responsible for planning and executing global regulatory activities necessary to obtain and maintain regulatory approvals within the United States, Europe, Japan, Canada, and markets within Asia, Latin America, Central Europe, and the Middle East.
Responsibilities
· Develop US and international regulatory strategies and timelines for product submissions, identifying needs for bench, animal and clinical testing.
· Participate on Product Development teams, providing regulatory strategy, timelines, and deliverables.
· Prepare US and/or international submissions. Work with FDA, foreign regulatory agencies, and distributors to obtain product approval/clearance.
· Support Regulatory Projects for our parent corporation in Europe.
· Ensure relevant ISO and FDA Export requirements are met, as required.
· Review Change Orders and assess regulatory impact of product changes on US and/or international regulatory strategy and submissions per standard procedures.
· Review labeling, training, promotional and advertising material.
· Evaluate post-market incident reports and determine MDR/Vigilance, and/or other international filing requirements.
· Support post market regulatory compliance activities for US/International product approvals.
· Develop and maintain regulatory affairs department procedures.
· Other duties associated with regulatory affairs as assigned or required.
This position is located at our manufacturing facility in Rancho Santa Margarita, California and reports to the Sr. Director of Operations.
We offer competitive compensation, generous benefits including a 4-day workweek and the opportunity to make a difference in the lives of people everywhere.
Minimum Qualifications:
Education
· Bachelor’s degree in related field
Experience
· 3-5 years of US and international medical device regulatory submission/approval experience particularly 510(k)
· Knowledge of FDA, EU and other international requirements
Other Skills
· Regulatory Affairs Certification (desired)
For consideration, apply via email to martins@gishbiomedical.com. No phone calls, please. All resumes must be accompanied by compensation requirements at the time of resume submission.
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