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Posted: Tuesday, March 14, 2017 4:31 AM

Job Description:/h3:
This position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry.

Job Duties:
:Assists in the preparation of regulatory applications (including annual reports) to achieve departmental and organizational objectives.
:Creates, reviews and approves engineering changes.
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Acts as a regulatory representative responsible for review and analysis of applicable regulatory guidelines.
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Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates.
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Maintains pertinent domestic and international medical device regulations to ensure submission requirements world:wide are current, up:to:date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel, if requested.
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Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
:May interface directly with FDA and other regulatory agencies if so directed.
:Reviews protocols and reports to support regulatory submissions.
:Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
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Complies with U.S. Food and Drug Administration (FDA) regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
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Performs other related duties and responsibilities, on occasion, as assigned.
Company Description:/h3:
We are committed to facilitating the delivery of optimal care options for our patients. This is achieved by providing high quality research facilities to our sponsors where the research is completed and data obtained by capable and caring Clinical Research Coordinators and Physician Researchers. Our culture is based on a strong work ethic, a genuine willingness to do anything to support the team, and a constant desire to be the best version of ourselves. It is our mission to commit to excellence, keep an open mind, and stay true to ourselves. Respect the product, the process, and each other. Stay inspired, achieve greatness; above all, care.

Source: https://www.tiptopjob.com/jobs/64862225_job.asp?source=backpage


• Location: Los Angeles

• Post ID: 104770663 losangeles
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