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Job Profile
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Top Echelon Network
Director of Regulatory Affairs
Job Location: Tucson, AZ
Salary: 100000 - 140000
Direct the companys quality management program including implementation and maintenance of total quality management principles and tools to promote continuous improvement of systems, product and service quality. Responsible for regulatory compliance and oversee services related for achieving medical device classification and product approvals, e.g., 510(k)s, Health Canada, and EU, and including post-market complaint handling, reporting, and field corrections. Perform and oversee product regulatory planning and approvals, safety complaint investigation, customer and agency notifications, and tracking and reporting of field corrections including PSN/CN efforts.
Responsibilities:
Define and gain executive support for the companys quality management program including the quality system, and corporate quality programs and procedures.
Accountable that the company is operating in accordance with ISO and FDA standards and maintains associated certifications and positive audit results.
Accountable for effective quality processes including procedures, documentation systems, tools, metrics and measurable improvements that are required to meet quality system standards.
Accountable for escalating any unresolved violations or concerns.
Provide guidance and direction on procedures and requirements for meeting FDA and ISO standards.
Provide decision and final judgment on quality issues on risk acceptability.
Ensure activities related regulatory quality and metrics are captured and available for Regulatory inspections.
Provide oversight to internal audits on process, CAPA, and proper document and record control.
Manage activities related regulatory compliance including site audits, 510k, 513g, HIPAA and other government-mandated requirements.
Interact with government agencies, healthcare organization, and medical professionals.
Provide regulatory training to assure awareness and understanding of compliance regulations.
Ensure appropriate communication clients, as needed on product safety issues.
Provides communication, guidance and direction teams on government related requirements.
Provides senior management with guidance on mandated or industry changes that impact Regulatory compliance.
Manage all employee related activities (i.e., hires, trains, appraises, rewards, motivates, disciplines).
Provide ongoing development, feedback, coaching, and mentoring to the Regulatory Team.
Requirements:
Bachelors degree in Medical Technology, Computer Science, or equivalent work experience in a Regulated Healthcare Industry.
10 years experience including management and experience with applying quality processes and procedures in a software development environment.
Experienced with application of FDA and ISO quality standards in a government regulated healthcare industry.
Ability to quickly grasp technology, medical applications, and applicable regulations/standards.
Ability to create and effectively communicate regulations/standards.
Ability to positively influence groups across an organization to embrace a common philosophy.
Ability to manage and execute on multiple, critical projects simultaneously.
Strong ethics to escalate issues in the face of competing corporate priorities.
Click Here to Apply
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