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Sr. CRA - Regulatory Affairs Specialist

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Location: San Francisco Bay Area - East Bay

Purpose of Role:
As a member of the Clinical Team, the successful candidate will: • Contribute to identification, evaluation and development of personnel experienced with requirements of Good Clinical Practice (GCP) and the specific regulatory environment for the region. • Maintain of strong professional relationships with clinical investigators/coordinators, clinical and scientific advisory boards, and contract clinical management firms needed to support the Company’s clinical trial programs. • Maintain and/or establish Standard Operating Procedures (SOP) and process to facilitate and ensure compliance with all applicable clinical regulations. • Work in compliance with clinical study quality system feedback mechanisms (e.g., CAPA) • Provide metrics regarding study compliance (e.g., i/e criteria , deviations) • Establish Charter and process for CEC and DSMB. Oversee SAE adjudication process and run CEC and DSMB meetings. • Interact with the medical advisors regarding adjudication, CEC and DSMB. • Oversee the preparation of all documents and clinical reports necessary to support all regulatory filings with the FDA and international regulatory agencies. • Oversee the effective negotiation of contracts with hospitals, consultants, investigators, CROs, database management firms and outside suppliers. • Oversee the Management of device accountability for trial sites ready to enroll subjects. • Conduct clinical site audits, Core Lab audits, CRO audits and internal audits, as necessary to support regulated activities. • Review promotional and educational materials for appropriate clinical content. • Present periodic study status updates. QUALIFICATIONS The profile of the desired candidate will include: • Currently serving as a CRA, Regulatory Specialist or CA/RA Manager in a medical device organization (Class III/PMA devices), minimum of 5-7 years of experience in clinical device research in pre-market trials. Experience in the neurological or cardiovascular space is highly desired. • Completion of a Bachelor’s level degree in bioengineering, nursing or life sciences. • Successful contribution toward a major U.S. and European, multi-center, prospective pivotal clinical trial - through all phases of development, from initiation, site selection and trial execution. Experience with trials outside the US (OUS) preferred. • Manage budgetary requirements and ensure compliance of expenditures to meet budgets. • Be an effective team player interfacing well with Marketing, R&D, Engineering and Quality. • High energy and results-oriented individual who is successful in a business environment and is skilled in motivating and inspiring people. • Small company, “hands-on” experience. • Strong written, verbal and presentation skills, including accomplished public speaking skills with the ability to present, persuade and convince regulators, investors and key opinions leaders with respect to the company’s products and clinical/regulatory strategies. • Provide the necessary reporting materials and communicate effectively with all levels of the organization. WORKING CONDITIONS • Light work, exerting up to 20 lbs. of force or less • Significant work pace & pressure due to deadlines • Sit or stand for 8 hours per day • 20-30% travel required TRAINING REQUIREMENTS • Quality Management System • Regulations and Standards • FDA Quality System Regulation (QSR) • EN ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes • EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects • EN ISO 14971:2009 Medical devices - Application of risk management to medical devices • EU Directive 90/385/EEC (Active Implantable Medical Device Directive) Qualified candidates please reply to: Cindy Johnson tel: 925-577-8135

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Chozen, Inc. 21001 San Ramon Valley Blvd., Suite A4-147, San Ramon, CA 94583  T: 925.242.1010 F: 925.886.8600