Senior Regulatory Affairs Specialist

Location: Dallas, Texas, USA
Salary: US$40 - US$50 per hour + competitive
Job Type: Contract
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Are you a personable and easy going individual that takes initiative into tasks? Are you interested in working at a growing company within an innovative industry? If you answered "Yes" to these questions, I have the perfect opportunity for you!

My client, a premier medical aesthetics company that is dedicated to helping lead aesthetic practices through science and emerging technology and focused on creating Medical Devices, Cosmetics, and OTCs, is actively searching for a Senior Regulatory Affairs Specialist to join its team in Dallas, Texas. This will be structured as a 6 month contract-to-hire and pay is competitive based on prior experience. The Senior Regulatory Affairs Specialist will be responsible for assisting, supporting, and maintaining procedures relating to global compliance for medical devices.

Among others, this role will take on the following responsibilities:

  • Manages the FDA Class II medical device submissions & CE Mark product updates.
  • Responsible for EU Medical Device Directive 93/42/EEC and Class I, IIa, and IIb Medical Devices with the transition to MDR compliance.
  • Responsible for in-country device registrations, supporting medical device registrations globally, such as Canada, Australia, Europe, UAE, Saudi Arabia, Asia, and other countries.
  • Assist the Medical Affairs Department with documentation as needed for domestic registrations, such as Clinical Evaluation Reports.

The best candidates for this role will possess the following basic qualifications:

  • B.S./B.A. in related discipline or equivalent combination of education and experience
  • 5+ years of experience in Regulatory Affairs within the medical device industry
  • Experience with Global Registrations for several countries, such as EMEA, Health Canada, Australia, EU, Asia, etc.
  • Experience submitting and authoring a 510k
  • Knowledge & experience with EU MDR, MDSAP, & Regulatory Labeling

The Senior Regulatory Affairs Specialist is an outstanding opportunity to take on immediate leadership and grow within a top notch organization, and located in a Dallas, TX!

If you are interested in learning more and/or applying, please reach out to me on the details below!

Sthree US is acting as an Employment Business in relation to this vacancy.

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