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Top Echelon Network
Director of RA/CA
Job Location: Palo alto, CA
Salary: 140000 - 180000
This position is responsible for all activities related to regulatory affairs and clinical affairs for worldwide markets and the manufacturing facility. This position will serve as the Management Representative.
Responsibilities:
As a focal point, lead the regulatory and clinical efforts of the organization.
Contribute and influence both the strategy and day-to-day management.
Develop and implement the functional annual operating, resource, and capital budgets to meet both short and long-term company and department objectives.
Participate in the planning of long-term product development programs, short term projects, and technology or business acquisitions.
Identify clinical strategy, plan, prepare, and coordinate clinical research and trial activities. Establish collaboration with research centers and corporate partners.
Identify, plan, prepare, review, and direct regulatory submissions (e.g., IDE, 510(k), Design Dossier) in support of timely launch for new and evolving products.
Serve as primary liaison and maintain effective working relationships with regulatory agencies (e.g., FDA, TV, Japanese MHW, Canada HPB, California Food and Drug Branch) on all matters.
Proactively provide advice to Senior Staff regarding current regulatory and clinical issues, requirements, and trends, and assure communication throughout the organization.
Participate in Strategic Advisory Board meetings.
Drive continuous system, process, and product improvements throughout the organization.
Serve as Management Representative with the authority and responsibility to ensure the requirements of applicable quality standards are implemented and maintained.
Recruit, interview, hire, train, manage, and develop internal regulatory affairs and clinical affairs resources, or utilize external resources and consultants, to achieve company objectives.
Carry out managerial responsibilities in accordance with the organizations policies and applicable laws.
Carry out responsibilities in accordance with the organizations policies and applicable laws.
Support the Quality Policy and Quality System.
Other duties as assigned.
Requirements:
This position requires 10+ years experience in the medical device industry with 5 years progressive management responsibility and a Bachelors degree in Engineering, Biology, or other science, or equivalent.
Masters degree is a plus.
Demonstrated ability to successfully work with individuals, teams, staff, and senior management.
Strong ability to influence and work with personnel at all levels.
Ability to effectively and convincingly present information to senior, Board, and regulatory agency staff.
Demonstrated credibility and leadership with regulatory officials.
Outstanding organization, interpersonal, negotiation, time/project management, motivational, and judgment skills.
ASQ and RAPS affiliation required.
Thorough understanding of FDA Medical Device QSR, ISO 13485, and European MDD requirements.
Demonstrated ability to effectively lead site inspections conducted by Regulatory Agencies.
Demonstrated ability to achieve timely regulatory clearance through US 510(k)/IDE, and European Design Dossier/ Technical File/ Clinical Dossier/ processes. Experience with achieving Canadian, Australian, and Japanese approvals a strong plus.
Accomplished at establishing clinical research, clinical trial, and clinical implementation strategy.
Experience interacting with physicians and Strategic Advisory Board members. PC proficient (e.g., Windows, Word, Excel, PowerPoint, Visio).
Click Here to Apply
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