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Category: Medical Device SubCategory: Quality Assurance JobNumber: DSM1059 Title: QA Manager-Director Region: New England Description: - Maintain company wide compliance with FDA 21 CFR 820, ISO 13485 and Medical Device Directive - Manage documentation control system including day to day processing of Engineering Change Orders and new specification release - Execute internal audit plan and implement corrective actions as required - Maintain and update SOP's as needed and provide training on SOP's and cGMP's - Supervise Inspectors to receive, inspect and release all incoming components and finished products to ensure they meet specifications - Assist with FDA and Notified Body Inspections and corrective action Maintain Technical files and update as needed to reflect changes to manufacturing and product design " Storage of production retainer samples " Ensure quality reporting systems are maintained and quarterly reports are issued in a timely fashion " Manage supplier base to ensure acceptable quality levels are maintained. Audit suppliers routinely and support operations by qualifying new suppliers as needed. " Create and maintain inspection procedures for device master records " Manage Inspection equipment and calibration systems " Acts as the primary team member with Product Development to ensure design control procedures are properly implemented. " Ensures corrective action system is properly implemented and follow ups completed in a timely manner. Qualification: Contact: Category: Medical Device SubCategory: Regulatory Affairs JobNumber: DBR001 Title: Director Regulatory and Clinic Region: Northern California Description: - Purpose of Position: The Director of Regulatory and Clinical Affairs will work within a multidisciplinary team environment to provide regulatory and clinical expertise and leadership. Major responsibilities include development and execution of regulatory/clinical strategies to support timely approval of regulatory applications in support of the company's corporate objectives. The position is also responsible for ensuring regulatory compliance within all markets in which Concentric products are marketed. Essential Functions: -Responsible for establishing the Regulatory/Clinical strategy for the development of new products and product enhancements to achieve marketable products in an efficient and effective manner. -Directs and executes domestic and international regulatory activities for investigational and marketed products ensuring regulatory compliance is maintained and regulatory clearances are obtained in a timely fashion in all targeted geographical regions. -Prepares and submits US regulatory market applications in support of the Company's corporate goals. Submissions include but are not limited to IDE, PMA, PMA(s), 501(k) applications and all related documentation and follow-up reports. -Interfaces directly with FDA staff and OUS regulatory agencies. -Reviews marketing brochures and other quality system documents to ensure compliance with the appropriate regulations. -Manages regulatory and clinical budgets. -Staffs/manages both clinical and regulatory departments ensuring that project timelines are met. -Supports marketing publications with analyses of clinical data. -Oversees the MDR, Vigilance and customer complaint reporting of Concentric products. -Ensures appropriate communication processes are established within and across functional groups. Communicates information related to quality management system effectiveness. -Works in accordance with quality system procedures. Qualification: Minimum Education: -B.S. degree in one of the life sciences or engineering required. Minimum Experience: A minimum of seven years of relevant industry experience in the development and execution of regulatory and clinical strategies leading to medical device market clearance/approval. Additionally, prior experience in a global regulatory development capacity leading multi-disciplinary teams is strongly desired. A minimum of four years supervisory experience required. Licenses, Certifications, Registrations: One or more of the following are desirable: Regulatory Affairs Certification (RAC), MS, MD or PhD. Other Essential Knowledge, Skills, and Abilities: -Ability to work well under pressure and to meet multiple and occasional competing deadlines while maintaining a cooperative working relationship with other employees and supervisor. -Ability to work in a highly detailed environment where mental focus and accuracy of work output is essential. -Experience in interfacing/negotiating with FDA and other regulatory bodies. -Must be knowledgeable in FDA regulations and international regulatory requirements, clinical research methods, basic statistical procedures and budgetary management. -Strong results driven, high level of enthusiasm and energy and an ability to demonstrate flexibility and integrity. -Good interpersonal and communication skills are required. -Leadership and people management skills that focus on teamwork and building alliances are essential. -Must be competent using MS Excel, MS Word and MS Powerpoint. Contact: bobr@nsasearch.com Category: Medical Device SubCategory: Clinical Affairs JobNumber: DBR002 Title: Director Clinical with Market Region: Northern California Description: JOB DESCRIPTION: The Product Planning and Development Manager for Emerging Indications will be involved in the development of new devices for neurostimulation applications, with specific responsibility to: - Work with team to identify, assess, prioritize, and specify new product opportunities to address new or expanded medical indications; - Define customer requirements for new product development projects; - Provide detailed marketing specifications of new products or product improvements to Research & Development team; - Gather market information by regularly attending major medical conferences and sales meetings, meeting with customers and field representatives, and conducting third party market research; - Acquire and analyze feedback from key opinion leaders, current and potential customers, third party market research and internal stakeholders; - Determine and lead both formal and informal market research to identify market needs and the corresponding product solution opportunities; - Work with Research & Development to advance projects that support a superior product plan; and - Work with internal resources to prioritize opportunities and focus resources upon projects with the greatest market potential. REQUIREMENTS: EDUCATION: - M.B.A. degree preferred - Degree in engineering or life sciences a plus EXPERIENCE: - 2 years of increasingly responsible experience in marketing PREFERRED EXPERIENCE AND ABILITIES: - New product development or product management experience strongly preferred - Medical device industry experience strongly preferred; experience with Class III devices preferred - Ability to complete assignments of an advanced degree of complexity, working under little or no supervision on specific tasks or problems Qualification: Clinical Marketing Director Provides clinical and technical support to staff and outside researchers and MD's. Activities will include providing assistance and information in the form of presentations, lectures, publications, clinical perspective on data analysis and sales support material. Travels with to accounts where clinical and technical expertise support are required to manage product issues, establish research studies or create future interest. Acts as a clinical advisor within the organization. Education: Engineering, Marketing, nursing. Contact: bobr@nsasearch.com Category: Medical Device SubCategory: Quality Engineering JobNumber: DBR003 Title: Sr. QE Region: Northern California Description: Summary of Responsibilities -Oversee implementation of design control requirements. -Conduct internal audits and be ready and responsive to inspectors. -Oversee the development and implementation of standards, methods and procedures for inspecting, testing and evaluating the performance and reliability of Hansen Medical products. -Establish and maintain QA standards based on internal and external specifications. -Enforce corrective actions necessary to assure conformity to quality specifications. -Assure finished products conform to government and company standards satisfying the QSR, ISO, Canadian and other foreign requirements. -Interface with other Hansen Medical departments to assimilate new technologies and to facilitate liaison with Manufacturing. Qualification: Requirements -An engineering degree or equivalent. -A minimum of 5 years experience within the Quality organization in a medical device company. Additional peripheral experience within Manufacturing, Engineering or Product Development desired. -Proven mastery of all aspects of the quality process, including standards, methods and procedures. -Solid organizational, analytical and problem solving skills. -Excellent interpersonal skills and ability to influence and negotiate. -Experience with quality systems for medical devices. -Experience with the QSR, Canadian and ISO 13485:2003 requirements. Contact: bobr@nsasearch.com Category: Medical Device SubCategory: Regulatory Affairs JobNumber: DBR004 Title: RA Manager, Sr. RA Specialist Region: Northern California Description: Summary of Responsibilities The Manager of Regulatory Affairs has responsibility for independently preparing and submitting regulatory submissions for the U.S., including letters-to-file, 510(k)s, PMA Supplements, U.S. IDE submissions, and interacting with regulatory agencies regarding submissions. The Manager is also responsible for preparing technical files and design dossiers, writing modification documentation and reviewing labeling to ensure compliance with regulatory requirements. Principal Duties: -Prepare and submit letters-to-file, 510(k)s -Prepare and submit PMA's and their Supplements -Prepare IDE submissions -Interface with regulatory agencies regarding submissions and clinical/regulatory compliance -Prepare technical files -Review labeling and advertising to ensure compliance with FDA requirements -Provide regulatory guidance and support to project core teams. Qualification: Requirements -A 3 year minimum of proven success in regulatory affairs. Work experience in medical devices is highly desirable. General knowledge of FDA regulations (current Code of Federal Regulations and FDA Guidances) required. -Education: A minimum of a BS degree in a scientific discipline such as engineering, physics, chemistry, biology or biochemistry. -Special Skills/Abilities: Attention to detail and accuracy, respond effectively to meet management objectives, self-motivated, and possess professional ethics, excellent planning and organizational skills, excellent oral and written communication skills, strong interpersonal /group skills, capable of working collaboratively with colleagues in all functions, ability to understand and comply with domestic and international regulatory requirements. Contact: bobr@nsasearch.com
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