Regulatory Affairs Specialist Job at PROJECTUS, Austin, TX

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  • PROJECTUS
  • Austin, TX

Job Description

As a Regulatory specialist in Medical Devices, are you feeling like a 'cog in the wheel' of a medium or larger organization?

Would you like to be working within a smaller, more agile and fast-moving business?

Where you're voice is heard, where your work is visible and you're rewarded as such?

We're representing an industry known Regulatory & Clinical specialist, who were founded (and still owned) by one of medical devices true Regulatory pioneers; someone you will have direct guidance & mentorship from - due to the flexible & dynamic nature of this organization.

Managing multiple projects & companies, you will play a pivotal part in all stages (and stakeholders) of the device (typically II & III) regulatory process.

To be clear, your responsibility will be far and wide; tasked with, and responsible for all stakeholders including direct liaison with the FDA.

This business are called upon and known for, tackling the toughest and most rewarding regulatory challenges device innovators face; you will be at the heart of it.

The role will be hybrid/remote working closely with & alongside your colleagues across 2 offices (1 in Texas, 1 in North East).

The position is exceptionally rewarding, and your development will sky rocket - expect 2 years with this company, the equivalent of 5-7 years in another company.

There are NUMEROUS examples of others in this function, performing in this company at Regulatory Manager level for 2-3 years - going on to secure larger positions internally and beyond.

**Unfortunately the company are unable to provide sponsorship for non-American citizens**

Your background?

  • 3+ years Regulatory Affairs experience with Class III Medical Devices
  • Experience and understanding with IDE's, PMA & 510k submissions
  • Hungry to learn, be exposed to challenge & take on extra responsibility

Job Tags

Remote work, Flexible hours,

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