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Job Field: Security
Location: Irvine, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Principal Accountabilities
Provides clinical and technical safety oversight
of Covidien Neurovascular NV products.  The
strategic collaboration  will include  Research
and Development, Quality Assurance and Medical
Affairs.  Provides medical input and oversight in
establishing and maintaining appropriate risk
management plans for all NV products, including
DFMECA. UFMEA, Health Hazard analysis, and Risk/
Benefit analysis.
Provides clinical and technical support of
Covidien Neurovascular NV products.  The support
will collaboration and advisement of Quality
Assurance and Medical Affairs in addressing
complex medical inquiries including off-label
issues.
Compose and maintain specialized response
letters and medical to medical communication.
Evaluate all NV post-market surveillance Adverse
Events, patient initiated files, legal, and
medical/scientific literature.
Serve as a corporate safety officer in the
monitoring/ report of adverse events occurring in
NV Clinical Trials pre  post market
Review competent authority requests and aide in
timely response.
Retrieve, disseminate, and archive pertinent
safety data/ reports to appropriate parties.
Participate on cross-functional teams concerned
with development or support of products as needed.
Provide professional consultation in matters
related to safety, efficacy, and proper product
usage as needed.
Prepare and deliver scientific presentations to
internal and external customers.
Comply with all relevant related guidelines,
standards and regulations pertaining to medical
information provided to customers.
Maintain Standard Operating Procedures SOPs
for responding to unsolicited requests for medical
information. Additionally, create SOPs for other
processes as required.
Collaboratively and effectively communicate with
various departments, including Legal Affairs,
Regulatory Affairs, R  D, Engineering, Business
Development Leadership, Marketing, Sales, and
Customer Service.
Performs internal quality assessments of
information provided by Covidien personnel.
Requirements
MINIMUM REQUIREMENTS
Education required/ preferred Bachelors Degree
in Nursing.  Advanced degree preferred
Experience Minimum of 8 years relevant
experience, preferably in the medical device
industry.  Neurovascular/ Endovascular experience
preferred.
Preferred Skills/Qualifications
Ability to perform patient assessment
Exceptional interpersonal skills and willingness
to work in a team environment
Well developed communication skills
Ability to work with a minimum of supervision.
Effective analytical and problem solving.
Ability to coordinate and lead multiple projects
simultaneously.
Knowledge and proficient use of Microsoft Office
Suite Applications Word, Excel, Power Point, and
Microsoft Project.
Skills/Competencies
Other Skills
ORGANIZATIONAL RELATIONSHIPS/SCOPE
For more information please go to URL.

KEY REQUIREMENTS:

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None Bachelors degree