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Job Field: Legal Jobs
Location: Fremont, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Senior Regulatory Affairs Specialist Job ID: JM20120310-27671 Requirements:Expertise Legal and ComplianceEducation BachelorsJob Type Full-timeLocation United States - California - FremontJob Level ExperiencedDescription:Position Summary:Responsible for preparation of regulatory submissions required tomarketnew or modified in-vitro diagnostic devices in both domestic and international markets including all relevant maintenance activities.Major Responsibilities:&middot;    Acts as a core member on development teams to provide regulatory guidance, and develop regulatory strategies and timelines.&middot;    Prepares documents necessary for new product market clearance, approval, and continuance during product life cycle management that includes (but is not limited to) 510(k)s, supplements, pre-IDE, and technical files for CE marking.&middot;    Prepares and/or compiles information required by ex-U.S. regulatory associates to support registration or licensing products outside the U.S.&middot;    Interacts with applicable regulatory bodies.&middot;    Participates in inspections/audits by the notified body or other international regulatory bodies by producing requested documents or answering any inquiries for information.&middot;    Interacts with R&D and other cross functional departments to ensure proper coordination of information to meet regulatory requirements.&middot;    Reviews and approves change orders.&middot;    Acts independently to determine and coordinate methods and procedures on new assignments.Minimum Requirements and Qualifications:&middot;    B.S. degree in a scientific discipline (i.e. Biology, Biochemistry, or Chemistry)&middot;    Minimum of 5-8 years related experience and/or training or equivalent combination of education and experience in diagnostics or medical device.&middot;    Must be able to write clear, understandable technical documents, i.e. regulatory documentation or scientific presentations.&middot;    Ability to compile data and summarize results.&middot;    Current knowledge of FDA QSR 21 CFR 820, U.S. medical device and in vitro diagnostic regulatory requirements, IVD Directive requirements and ISO standards.&middot;    Post market experience preferred, 13485 experience preferred

KEY REQUIREMENTS:

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