Senior Regulatory Affairs Specialist

  • OsteoMed
  • Addison, TX
  • Mar 21, 2019

Job Description


Equal Employment Opportunity/M/F/disability/protected veteran status.

Senior Regulatory Affairs Specialist
Addison, TX, US

Rethinking Possibilities, Reshaping Lives

OsteoMed is a leading global innovator, developer, manufacturer and marketer of specialty medical
devices, surgical implants and powered surgical instruments.

Our mission is to improve patient outcomes through the design, manufacture, and service of high quality,
innovative and cost effective surgical products.

We value teamwork based on trust, respect & communication. We hold our employees accountable by
empowering them and recognizing their initiatives. If you are looking for a company who values its employees, apply today!

OsteoMed is looking for an experienced Sr. Regulatory Affairs Specialist with a minimum of 5-7 years experience working in FDA regulated industry at its Corporate office in Addison, TX.

What do I need?
  • Working knowledge of domestic and international Medical Device Regulations (21 CFR 820, CMDCAS, MDD,
    ISO 13485, ISO 14971)
  • 510(k) experience required
  • Experience in Orthopedicseindustry preferred
  • RAC preferred
  • B.S. or B.A. degree in scientific or technical discipline

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.

Requisition ID 1111