To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #02494

About our client Our client provides solutions for identifying and pinpointing cancer in the developmental stage itself. These solutions are based on Computer-Aided Detection technique (CAD). The company helps healthcare professionals serve patients better. It caters to the mammography markets and offers a broad range CAD systems. These are high-performance and upgradeable systems. More than a thousand women’s healthcare centers around the world trust the company for early detection of cancer. Position Location Vice President, Quality Assurance and Regulatory Affairs New Hampshire, Ohio Salary Highly competitive package, commensurate with experience Responsibilities 1) Establish and manage implementation and improvement of an effective and efficient quality system 2) Ensure that the company’s quality system is in compliance with internal and external requirements such as ISO 9001, ISO 13485 and Quality System regulations 3) Secure FDA approvals for company products through PMA, PMA supplement and 510(k) submissions 4) Oversee the international regulation process for products requiring governmental approval 5) Ensure that all necessary applications are filed and handle all necessary interactions with government agencies 6) Interpret and incorporate FDA and other regulatory laws and standards through designing and processing 7) Obtain product certifications, submissions and licenses where necessary for US and worldwide market release 8) Oversee internal and external quality audits and work closely with operations staff to reinforce adherence to company standard operating procedures 9) Support planning and execution of clinical trials in support of Class II and Class III regulatory filings in accordance with Good Clinical Practices (GCP) 10) Support development of standard operating procedures to ensure regulatory compliance 11) Report quality system performance to Senior Management and implement improvements 12) Investigate and monitor quality problems with products, processes and/or the quality management system 13) Promote awareness of regulatory and customer requirements throughout the organization Requirements 1) Bachelor's degree with a minimum of 10 – 15 years of progressive QA/RA leadership experience in the medical device industry 2) MS in technical field (preferred) 3) Experience in Class III medical devices is highly preferred 4) Strong understanding of PMA and 510k processes as well as relationship with the FDA 5) Experience in coordinating and creating documentation for submission of new products for a 510(k) (United States; FDA), technical file (European Community; CE Mark) or other international regulatory agencies 6) Experience in establishing and maintaining corporate procedures as they relate to the FDA Quality System Regulations, ISO 9001, ISO 13485 and the Medical Device Directive 93/42/EEC 7) Experience in working in a developmental-stage engineering environment in creating and documenting prototype devices 8) Familiarity with providing support through design and manufacturing phases with regards to FDA regulatory requirements, documentation, testing and inspection 9) In-depth knowledge of Good Clinical Practices (GCP) 10) Ability to implement design controls with emphasis on the creation of Failure Mode and Effects Analysis (FMEA), design review and safety regulations 11) Ability to interpret regulatory standards 12) Positive attitude and a team player with exceptionally good interpersonal skills 13) Ability to communicate with highly specialized research and development scientists, engineers and marketing people 14) Excellent communication skills – verbal/written