SRG, the leader in the Life Sciences human capital industry, is looking for a contract MRegulatory Affairs Specialist to operate remotely in the US. This position serves as the Regulatory Affairs lead on cross-functional MDR project teams for our client.

JOB RESPONSIBILITIES include, but are not limited to:

• Ensures compliance with EU Medical Device Regulations (MDR) and EU guidance throughout the project.

• Actively participates in EU MDR project teams by attending meetings, collaborating with the project manager and cross-functional team members, and communicating regulatory requirements and guidance for the technical documentation.

• Review change orders associated with the MDR project deliverables.

• Writes and assembles information necessary for the technical documentation and works with the publishing department to finalize submission.

• Leads the preparation of the General Safety and Performance Requirements (GSPR) with the cross functional team.

• Prepares and submits EU MDR technical documentation submission for applicable device per project

WHAT YOU NEED TO HAVE:

• Bachelor's degree in Science, Engineering, Regulatory Affairs, or other technically related field.
• Minimum of 3-5 years regulatory experience in a regulated industry such as Medical Devices, Biotech
  or Pharma
• Excellent written and verbal communication skills.
• Experience in the preparation and submission of EU MDR technical documentation submissions,
  including EU Class II and III devices.
• Leverages scientific and technical understanding of regulated products within scope of responsibility
  to provide regulatory input to MDR project teams.

ADDITIONAL INFORMATION:

• Normal office environment: must be computer literate and familiar with Microsoft Suite of Products

  including Word, Excel, Outlook or similar.
  
  

** "SRG values your application, our team will be in touch to schedule interviews with candidates moving forward in the process."

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.