Software Medical Device Regulatory Professional

3 days ago


Alameda, California, United States Collabera Full time

We are looking for a talented Software Medical Device Regulatory Professional to join our team at Collabera, a leading global digital solutions company.

About the Role

This is an exciting opportunity to work with innovative technology and contribute to the success of our clients.

As a Software Medical Device Regulatory Professional, you will be responsible for ensuring that our software engineering solutions comply with relevant regulations and guidelines in the medical device industry.

With a strong background in regulatory affairs and experience in submissions to US FDA and international regulatory authorities, you will play a key role in supporting our impact assessments and connecting with 3rd party vendor apps.

Responsibilities include:

  • Performing regulatory assessments and communicating requirements and regulatory questions/responses with stakeholders.
  • Supporting impact assessments with internal and external software partners.
  • Connecting with 3rd party vendor apps that need to partner with devices and the regulations needed.

Required qualifications include:

  • 3+ years of experience in Regulatory Affairs in the medical device industry.
  • Degree in science, engineering, or medical fields.

Estimated salary: $55-58/Hr.

We offer a competitive pay range and opportunities for professional growth and development.



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