New job MEDICAL DEVICE JOB OPPORTUNITY: Director, Regulatory Affairs -- North Carollina -- SALARY: $130,000-$150,000

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Group: JOBS 2.0: Job Search Career Networking Staffing. Post Resume -Get Paid by Employers at Resumark .com Subject: MEDICAL DEVICE JOB OPPORTUNITY: Director, Regulatory Affairs -- North Carollina -- SALARY: $130,000-$150,000 Andy Ellis posted a job: MEDICAL DEVICE JOB OPPORTUNITY: Director, Regulatory Affairs -- North Carollina -- SALARY: $130,000-$150,000 "JOB SUMMARY: This position ensures compliance with the guidelines and SOP´s described by the company for subsidiary companies, within the legal and regulatory requirements of the United States (FDA) and Canada. The position also promotes safe and effective practices and procedures in the daily operation of the company, while maintaining open communication flow with the company on all matters of vigilance and Regulatory Affairs Process. The goal for this position is to: •Be the interface towards US FDA and Health Canada in the Regulatory processes for new product development and product maintenance. •Ensure compliance with FDA Guidelines for the distribution of the company products and any future devices within the cleared 510(k), Regulations and Guidelines for conduct of clinical trials and Product Vigilance. •Ensure compliance with Canadian Regulatory Health authorities for the distribution of the company products and any future devices. •Work closely with Quality Assurance (QA) to ensure compliance with 21 CFR Parts 820 and 11 and ISO-13485 requirements. JOB RESPONSIBILITIES: •Propose quality goals and objectives for the company management group. •Investigate new and changed regulatory requirements for medical devices, Conduct of Clinical Trials, and Product Vigilance. •Assure Regulatory requirements are adhered to in the company’s business planning and budget. •Provide regulatory support for handling, usability and clinical studies. •Review and evaluation of customer and clinical trial complaints for judgment on vigilance reporting decisions. •Coordination of activities needed for product vigilance reporting. •Lead development of US and Canadian Regulatory Strategy, 510(k) and License Application submissions and product certification. •Work with FDA and Health Canada to resolve any ongoing submission review issues. •Present current Regulatory strategy at both the Department and Executive Leadership Team levels. •Coordination with regulatory authorities and external quality agencies for ongoing regulatory requirements and submission(s) for North America. •Review and approval of documentation (marketing, technical and clinical) for compliance with GCP and ISO guidelines for conduct of clinical trials worldwide. •Participate in review of Clinical Protocols, Investigator Sponsored Study (ISS) applications, and Study Reports to determine Regulatory and Product Safety impact. •Work with QA during internal audits of the company facility and external audits of investigative sites, vendors, and suppliers and submits report of findings to management. EDUCATION & EXPERIENCE: •Minimum 4 year BS degree; with a minimum of 10 years of experience in Regulatory Affairs. •ISO-13485 trained. •FDA 21 CFR trained. •Ten (10) years supervisory experience. --- all interested applicants please send resumes to andyellis@pellis.com"

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