Director, Regulatory Affairs & Quality Assurance

The Director of Quality Assurance and Regulatory Affairs (RA/QA) works closely with the Division VP to ensure a compliant and efficient medical device quality system is maintained which will easily withstand audit by regulatory agencies and third parties. In addition, this group oversees Radiation Safety, which is responsible for worldwide licensing and compliance of all Varian devices, workers and sites. Working with Regulatory Authorities to secure and maintain medical device approvals, ensure the ethical and compliant conduct of clinical studies and reporting of medical device complaints and recalls are all within the scope of responsibility. The position has worldwide responsibility for all VOS sites (12 in all) and is seen as a highly visible RA/QA expert within VOS and other Varian divisions. The position also works closely with Corporate groups including Corporate Regulatory Affairs and Compliance. The Director of RA/QA is a strong advocate of not only medical device quality system and process excellence but best industry practices from all allied areas. Familiarity with Six Sigma is important but more important the wisdom to judiciously use relevant metrics and process improvements. Verification and Validation in both medical device product development (including packaging and sterilization) and process, will not only be familiar but are subjects which the Director can analyze and explain in clear and concise terms. The Director should be well versed in US, EU and Canadian requirements, and experience with SFDA, TGA and other agencies is desirable. Familiarity with Normative Standards applied to medical devices, including radiation emitting devices, sterile products and some familiarity with combination products (drug-device, biologics-device) is an important part of the expertise this position brings to the company. This position will lead several of the RA/QA functions directly, and hold primary responsibility for those functions which may include domestic and international sites. Exceptional visibility to top Varian management, Board of Directors and management committees, International regulatory agencies and Industry provide opportunities to demonstrate communications skills which inspire confidence, and promote clarity. Overall Responsibilities:1. Divide primary responsibility of several QA/RA functions with Division VP depending on experience and expertise. 2. Manage a variety of RA/QA projects independently including new products, new process, submissions/approvals, clinicals, technical studies, regulatory negotiations etc.3. Lead and inspire QA/RA and operating groups internationally.4. Interpret and communicate efficient solutions to worldwide regulatory compliance.5. Advocate Quality compliance, efficiency and excellence. Actively drive improvement programs to achieve world-class quality excellence. 6. Lead or provide key support to regulatory inspections and actions worldwide.7. Support and maintain outstanding record of Radiation Safety, regulatory cooperation and trust.8. Create and manage group budgets and capital projects9. Lead cross functional teams in deployment of enterprise applications, corrective actions, process improvements, acquisitions and integrations, and regulatory solutions. 10. Support due diligence Merger & Acquisition activities as required11. Support contract negotiations with partners and key suppliers.12. Attend industry events and training. 13. Monitor the regulatory and quality environment and integrate new ideas, standards and risk mitigation into department and company goals.VARIAN MEDICAL SYSTEMS is firmly committed to a policy of equal employment opportunity and will administer its Human Resources policies and conduct its employment practices in a manner that treats each employee and applicant for employment on the basis of merit, experience, and other work-related criteria without regard to race, color, religion, sex, national origin, ancestry, sexual orientation, age, marital status, medical, disability (mental or physical), veteran status, or any other protected class under relevant state and federal laws. For this position reply to: Varian Medical Systems