Sr. Manager Regulatory Affairs-Medical Device/Diagnostics

 Position ID: bt-smregsff-m  Job Category: Biotech/R&D/Science  Type: Full Time, Employee  Minimum Education: Bachelor's Degree Sr. Manager Regulatory Affairs-Medical Device/Diagnostics Our client, located in the San Francisco Bay area, is a global leader in developing and manufacturing molecular diagnostic products that are used by hospitals and other clinical laboratories to detect, characterize, monitor and select treatment for disease. Job Responsibilities: Prepare FDA and international submissions for new products and product changes (510K,PMA) Negotiate submission issues with FDA and international regulatory agencies Develop domestic and international regulatory strategies Maintain regulatory product files to support compliance with regulatory requirements Provide support to new and currently marketed products; reviewing labeling, promotional material, product changes and documentation for changes Manage and provide training to regulatory department personnelJob Qualifications: Bachelors Degree in science or engineering. 5-10 years medical device/diagnostics experience. Knowledge of FDA, Health Canada and EU as it pertains to regulatory registration regulations Effective oral and written communication skillsCompensation: $120,000.00 (compensation commensurate with experience and current compensation package). Excellent benefits and relocation assistance. For confidential consideration, please forward your resume in a Word document to: bthornton@kleinhersh.com  Visit www.kleinhersh.com to view other job opportunities available through our company.  Company: MRINetwork  Contact Name: Bill Thornton  Email: Apply by Email Klein Hersh International is your connection to the best and brightest people involved in the Life Sciences and Information Technology industries. We are immersed in all aspects of the drug lifecycle- touching everything from drug discovery through clinical trials, dealing with commercialization as well as regulatory affairs, outsourcing organizations, marketing and branding. Our IT Division is deeply entrenched in the Software segment of the business placing sales professionals to C level executives. We know the talent the market demands and can help your organization reach its hiring goals! As a global leader in the Pharmaceutical/Biotech arena and Information Technology, Klein Hersh International has years of deep industry expertise and a large thriving network of contacts. Let us put it to work for you! Whether your company needs a contract or permanent executive level solution, we can help! Please visit us at www.kleinhersh.com to learn more.................. MRINetwork is one of the world's largest recruitment organizations. Through our Accelerated RecruitmentT approach, we find and place Impact Players, those individuals who arrive faster, fit better and stay longer. Providing our clients immeasurable return on their hiring investment by bringing them the people who make a difference in their business every day. The combination of our global reach, industry expertise and streamlined methodology allows MRINetwork to match companies with their Impact Players - the right candidate for the right position. MRI is a registered trademark licensed to Management Recruiters International, Inc. An Equal Opportunity Company Each office is independently owned and operated.