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    <job>
        <title><![CDATA[DIRECTOR, REGULATORY AFFAIRS]]></title>
        <description><![CDATA[Title: DIRECTOR, REGULATORY AFFAIRS
Location: CA-Santa Ana
AMO is focused on providing the full range of advanced refractive technologies and support to help eye care professionals deliver optimal vision and lifestyle experiences to patients of all ages.
Ophthalmic surgical products include intraocular lenses, laser vision correction systems, phacoemulsification systems, viscoelastics and related products used in cataract and refractive surgery. Contact lens and eye care products include disinfecting solutions, enzymatic cleaners, lens rewetting drops and dry eye drops. 
AMO is headquartered in Santa Ana, California, and employs approximately 3,600 worldwide.For more information, visitwww.abbottmedicaloptics.com. 
This position has responsibility for approval of all US cataract, corneal, and refractive products. This is accomplished by working closely with staff in Santa Ana and coordination with O.U.S. regional offices. These devices comprise a full range of Class I, II and III medical devices for which regulatory requirements can be cumbersome and complex. The senior-level RA professional in this position must strive to maintain awareness of emerging regulatory trends, and be able to device compliant and innovative strategies in order to achieve best-in-class approval times. 
The preparation of accurate project plans, budget forecasts, and personnel requirements is required for effective planning and for meeting business imperatives. The incumbent must effectively represent RA at external meetings to assure favorable positioning of AMO and our products. 
Duties and Responsibilities:
* Provide direction and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies, work plans and processes for all the business lines (corneal, cataract and refractive).
* Responsible for all business unit regulatory affairs for AMO&#39;s US regulatory approval submissions.
* Assist the Clinical Research Department as required to assure regulatory approval.
* Responsible for regulatory strategy for new product approvals, advertising and promotional claims and registration requirements for IOLs and associated devices.
* Contributes to RA strategy development for all AMO products in US.
* Assures that AMO attracts and retains good regulatory affairs talent through coaching and communication among regulatory affairs staff. 
* Responsible for promptly informing senior management of any changes in the regulatory status of AMO products and any significant regulatory issues.
* Represent AMO before regulatory authorities and on standards committees and trade association working groups.
* Provide counsel, training, and interpretation of FDA and other regulatory issues to AMO personnel and assist as a liaison between AMO and regulatory authorities.
* Assist in compliance with the Medical Device Directive (MDD) in the EU, Canadian Medical Device Directive, and other regulatory agency requirements.
* Ensures that all functions comply with the requirements of ISO 13485, ISO 14971, the FDA Quality System Regulation, the European Medical Devices Directive and other pertinent international regulations and guidance documents.
* Reviews, prepares, and conducts department organizational assessments, training and standard operating procedures. Interprets and applies Good Clinical Practices, FDA regulations, and maintains familiarity with current literature in the specialty area. 
* Collaborates with Clinical Research, Marketing, R&amp;D, and in-house and outside authors, investigators, and consultants.   
The range of devices falling under this position will depend upon the candidate or incumbent&#39;s knowledge, experience, skills and abilities. This individual will be responsible for Corneal, Refractive and Cataract products including intraocular lenses and related accessories such as cartridges and inserters.  Responsibility could be expanded to include other categories of AMO products. Devices in these categories are complex and are regulated in the highest device classification tier.  
 
Education:
BS degree in science or related fields
Experience:
* BS. 12 or more years Regulatory Affairs Experience  4 yrs spec exp
* MS. 9 or more years Regulatory Affairs Experience  4 yrs spec exp
* PhD. 6 or more years Regulatory Affairs Experience  4 yrs spec exp
Certifications/Licenses:
RAC certification desirable
Technical Skills:
Product knowledge gained on the job
Other:
IDE/PMA experience desirable; 510(k) experience required if lacking recent IDE/PMA experience.

Abbott Medical Optics offers a competitive salary and generous benefits package. This includes healthcare coverage, 401(k), and much more. At AMO, people make the difference and have the opportunity to be a part of a global company that is a major force in the medical device industry. AA/EOE M/F/D/V
]]></description>
        <link><![CDATA[http://jcnlx.com/f74047f9380246db8b70d425e2df9a99105]]></link>
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        <industries />
        <expiration_date>2009-11-27</expiration_date>
        <employer><![CDATA[Abbott Medical Optics]]></employer>
        <location><![CDATA[Santa Ana, CA, 92702, USA]]></location>
    </job>
    <job>
        <title><![CDATA[Sr. Complaint Investigator]]></title>
        <description><![CDATA[Title: Sr. Complaint Investigator
Location: CA-Santa Ana
Reviews complaints for potentially reportable AE status, including evaluation and follow-up regarding MDR reporting. Completes MDR reports within regulatory timelines. Communicates with US FDA regarding individual complaints, as required. Escalates significant issues to QA management as needed.
Reviews complaint records prior to closure to ensure records are accurate, complete and compliant with all relevant requirements.
Coordinates corrective actions with AMO Manufacturing Sites to resolve complaint root causes and prevent recurrence.
Manages individual complaints on various AMO product lines, from opening to closing. Performs accurate and timely data entry in corporate complaint database. Coordinates complaint investigations, including determining investigation strategies, as needed with internal and external resources. Communicates directly with AMO customers regarding reported complaints and resolutions.
Receive, document, follow-up and close product complaints as reported from various sources.
Assesses individual complaints for adverse event reporting requirements according to US FDA regulations for medical devices and drugs. Writes reports as needed.
Analyzes complaint data for trends. Reports on trends to department management and other personnel. Works with other departments on known and emerging issues to resolve quality problems.
Reviews complaint records prior to closing to ensure compliant, accurate and complete records

Abbott Medical Optics offers a competitive salary and generous benefits package. This includes healthcare coverage, 401(k), and much more. At AMO, people make the difference and have the opportunity to be a part of a global company that is a major force in the medical device industry. AA/EOE M/F/D/V]]></description>
        <link><![CDATA[http://jcnlx.com/b52c73377e874cfbbd8d778caba9a3a1105]]></link>
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        <industries />
        <expiration_date>2009-11-27</expiration_date>
        <employer><![CDATA[Abbott Medical Optics]]></employer>
        <location><![CDATA[Santa Ana, CA, 92702, USA]]></location>
    </job>
    <job>
        <title><![CDATA[Territory Manager, Surgical]]></title>
        <description><![CDATA[Title: Territory Manager, Surgical
Location: PR-Aņasco
AMO is focused on providing the full range of advanced refractive technologies and support to help eye care professionals deliver optimal vision and lifestyle experiences to patients of all ages.
Ophthalmic surgical products include intraocular lenses, laser vision correction systems, phacoemulsification systems, viscoelastics and related products used in cataract and refractive surgery. Contact lens and eye care products include disinfecting solutions, enzymatic cleaners, lens rewetting drops and dry eye drops. 
AMO is headquartered in Santa Ana, California, and employs approximately 3,600 worldwide.For more information, visitwww.abbottmedicaloptics.com.  
* Position located in Puerto Rico.
* Achieves assigned sales goals through execution of U.S.marketing plans. Demonstrates an independent, creative, consultative/value based sales approach to selling IOLs, phaco equipment, viscoelastics and surgical adjuncts. Works synergistically with Laser Vision Correction Group counterparts as a means of providing customers with a full product solution. Selling time for IOLs, phaco and adjucts are consistent with current year marketing plan.
* Provides expert product knowledge with regard to surgical and refractive techniques, technical product support, inservice programs and innovative educational programs. Prepares and provides detailed sales/procedural/financial presentations to new and existing customers.
* 
Leverages and effectively utilizes all other AMO resources and sales personnel to include: Refractive Implant Specialists, Phaco Specialists, Corporate Accounts, Eye Care/LVC counterparts and strategic partners to enhance field productivity. This includes integration of the phaco in-service, innovative educational programs and CORE.
* 
Utilizes Customer Resourse Management System and computer hardware/software to enhance productivity. Prepares and submits on a timely basis all reports requested by management and marketing through use of e-mail.
* 
Effectively manages AMO field assets to include IOL consignments (achieve target consignment ratios), product samples (within assigned budget), surgical instruments, phaco demonstration equipment/accessories and computer hardware/software. Works toward achievement of established consignment goals and manages expenses within assigned budget. Files timely reports to the home office on surgical pharmaceutical inventory and sampling to comply with Dingell Bill requirements.
Minimum Requirements:
* Education: Bachelor&#39;s Degree or equivalent experience
* Field of Study: Marketing
* Experience: Minimum 3-5 years proven sales experience preferably in the surgical equipment or healthcare industry.
Essential Skills and Mental Abilities:
* Communication: Demonstrated interpersonal skills. Must have exceptional written and verbal communication.
* Coordination: Ability to lift 60 lbs.
Other: 
* Proven ability to self manage time and administrative tasks (pre-post call planning, territory routing / zoning, expenses, sample accountability, etc.)
* Ability to develop key strategies and execute.
* Independent, creative and innovative thinker who thrives on selling in a consultative selling environment.
* Strong problem resolution skills.
* Strong contract / negotiating skills.
* Proven sales ability with consultative approach.
* Proficient on Windows, Microsoft Word, Excel, and PowerPoint.
* Ability to travel.
Abbott Medical Optics offers a competitive salary and generous benefits package. This includes healthcare coverage, 401(k), and much more. At AMO, people make the difference and have the opportunity to be a part of a global company that is a major force in the medical device industry. AA/EOE M/F/D/V
]]></description>
        <link><![CDATA[http://jcnlx.com/278f763e576c439ea682ea6379c12857105]]></link>
        <imagelink>http://images.jobcentral.com/companylogos/abbottmo.gif</imagelink>
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        <industries />
        <expiration_date>2009-11-27</expiration_date>
        <employer><![CDATA[Abbott Medical Optics]]></employer>
        <location><![CDATA[, USA]]></location>
    </job>
</jobs>