Regulatory Technical Specialist 4
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POST DATE 9/16/2016
END DATE 10/18/2016
Mountain View, CA
JOB DESCRIPTIONSuperior Group is looking for Regulatory Technical Specialist 4 for our Client located in Mountain View, CA
Guide the decision making process on regulatory submission issues using historical knowledge, legal counsel and current regulations on medical device industry.
Perform the review of promotional material and device labeling for regulatory compliance.
Lead the PSG (Project Steering Group) to define effective regulatory strategies.
Ensure that the products and processes are compliant with internal and external requirements.
Gather all pertinent Quality and Regulatory documents.
Assure that the PSG members are complying with all aspects of the PLP & QMS process
Guide, write, and file the appropriate FDA/Agency submissions to ensure that products are legally commercially available.
Drive completion of global market regulatory approvals/registrations.
Communicate with regional units and external reviewers(FDA/Agency/3rd party) to provide appropriate input/feedback for product approval and establish/maintain country specific regulatory requirements.
Co-work with regional units to establish regulatory strategies for New/Update/Renewal projects.
Collect/Analyze/Communicate country specific requirements and implement new or changed requirements into internal requirements or processes.
Respond to inquiries from the PSGs and other stakeholders related to regulatory requirements and submissions.
Stay current with domestic and international submission regulations and quality standards/systems.
Participate in Product risk/hazard meeting and provide appropriate input
Support complaint handling/HRE/Recall/Adverse Event reporting
Communicate with relevant parties to provide appropriate post market reports in a timely manner.
Able to work under [periodic] intense time pressure to meet required deadlines
Able to work pleasantly and respectfully with others in a fast-paced, sometimes stressful environment
Required Skills / Qualifications:
Minimum of 2 years’ experience as Regulatory Technical Specialist
Preferred Skills / Qualifications:
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EEO Employer - Minorities / Females / Disabled / Veterans / Sexual Orientation / Gender Identity.