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Posted: Wednesday, September 6, 2017 8:48 AM

Job Description:/h3:
Job Summary:
This position supports domestic and international regulatory compliance for products produced and/or distributed by OsteoMed.
Duties and Essential Job Functions:
:Support New Product Development (NPD) and design change projects by participating in FMEA activity, ECN, Labeling, Advertising and Promotional material and Design Reviews.
:Provide regulatory strategic planning and support for new 510K products and indications through design control to submission.
:Perform regulatory review of Marketing and Engineering materials for New Product and Line Extension launches.
:Participate on project teams to determine, communicate and maintain global regulatory strategies.
:Prepare and create domestic and international regulatory submissions as well as supports the maintenance of technical files.
:Support audits (TUV, FDA and Others) as required.
:Provide work direction/guidance as needed to other specialists or associates.
:Lead and support Regulatory Department Process Improvement Initiatives.
Experience/Skills Required:
:Five to seven years work experience in FDA:regulated industry.
:Working knowledge of domestic and international Medical Device Regulations.
:Experience in Orthopedics industry is preferred.
:510(k) and global submission and experience required.
:Microsoft skills (Excel, Word, Access)
:Project management and process improvement experience.
Required Education:
:B. S. or B. A. degree in scientific or technical discipline.
:RAC preferred
:CQA, or RAB certification a plus

Additional Information:
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.
Company Description:/h3:
For more than two decades, OsteoMed has remained sharply focused on meeting the needs of surgeons and their patients by rethinking clinical possibilities with a focus on procedural efficiency, efficacy and uncompromised quality.
A highly nimble and responsive company, OsteoMed is a leading global innovator, developer, manufacturer and marketer of specialty medical devices, surgical implants and powered surgical instruments.
Our success is driven by the ability to quickly develop and deliver innovative, quality products focused on improving patient outcomes and offer technically advanced, simple and cost:effective solutions for surgeons, hospitals and patients. Our state:of:the:art manufacturing facility and world headquarters is located in Dallas, Texas. This allows us to offer remarkable responsiveness to those who count on our products.

Source: https://www.tiptopjob.com/jobs/71664317_job.asp?source=backpage


• Location: Dallas

• Post ID: 65365082 dallas
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