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About our client
Our client is a medical device company that designs, develops and markets products for restoring blood flow in patients who have suffered ischemic strokes, resulting from blood clots in the vessels of the brain.
Position	Location
Director of Regulatory Affairs	California
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Establish the regulatory strategy for the development of new products and product enhancements to achieve marketable products in an efficient and effective manner 2) Direct and execute domestic and international regulatory activities for investigational and marketed products 3) Ensure regulatory compliance is maintained and regulatory clearances are obtained in a timely fashion in all targeted geographical regions 4) Prepare and submit US regulatory market applications in support of the company’s corporate goals (i.e. submissions include but are not limited to IDE, PMA, PMA(s), 510(k) applications and all related documentation and follow-up reports) 5) Interface directly with FDA staff and OUS regulatory agencies 6) Review marketing brochures and other quality system documents to ensure compliance with the appropriate regulations 7) Manage regulatory budgets 8) Staff/manage regulatory department ensuring that project timelines are met 9) Support marketing publications with analyses of clinical data 10) Oversee the MDR, vigilance and customer complaint reporting of products 11) Ensure appropriate communication processes are established within and across functional groups 12) Communicate information related to quality management system effectiveness 13) Work in accordance with quality system procedures
Requirements
1) B.S. degree in one of the life sciences or Engineering 2) Minimum 7 years of relevant industry experience in the development and execution of regulatory strategies leading to medical device market clearance/approval 3) Minimum 4 years of supervisory experience 4) Medical device experience preferred 5) Experience in a global regulatory development capacity leading multi-disciplinary teams is strongly preferred 6) Experience in interfacing/negotiating with FDA and other regulatory bodies 7) One or more licenses, certifications and registrations preferred (i.e. Regulatory Affairs Certification (RAC), MS, MD or PhD.) 8) In-depth knowledge in FDA regulations and international regulatory requirements, clinical research methods, basic statistical procedures and budgetary management 9) Ability to work well under pressure and meet multiple and occasional competing deadlines while maintaining a cooperative working relationship with other employees and supervisor