Director of Regulatory Affairs in
Los Angeles County

Job Summary

The Director of Regulatory Affairs is responsible for all regulatory related activities within the organization, including but not limited to regulatory inspections and external audits and is required to maintain our continued FDA Establishment Registration and ISO compliance.  Regulatory Affairs activities include, but are not limited to, submission of technical information for domestic and international regulatory clearance/approval for medical devices and maintenance of all domestic and international regulatory affairs requirements.

Essential Functions

• Direct the regulatory related activities required for medical device design and manufacture
• Participate in design control activities with engineering to identify regulatory related issues during the design phases of device development and device modification
• Direct the regulatory affairs related activities required for medical device design and manufacture
• Work closely with Quality Assurance department to develop, establish and implement quality policies and procedures, inspection plans, quality performance trends and continuous improvement initiatives to assure devices meet specifications
• Participate in third party audits/assessments, recommend and manage external audits
• Interface/coordinate with customer to address/resolve regulatory issues and concerns
• Direct completion of domestic and international regulatory documents, including but not limited to: US FDA 510(k) submissions; MDD/CE/MDR technical files, design dossiers and/or technical documentation; post-market surveillance and post-market clinical follow up reports; clinical evaluation reports; and customer requested regulatory documentation
• Direct maintenance and evaluation of domestic and international complaint reporting requirements including adverse event reporting
• Provide training for regulatory-related topics to all members of the company
• Participate in professional organization, symposiums and continuing education that will promote and benefit company

Education/Experience Requirements

• Minimum 10 years experience in Regulatory Affairs
• Knowledge of regulations including QSR, MDD/MDR, and CMDR
• Bachelor’s degree or higher
• Excellent written and verbal communication skills
• Must be able to lift 20 pounds