Regulatory Specialist

Littleton,, Massachusetts | Freelance | Job ID #59522 |
Posted Earlier this month
 

Client in the Littleton Mass area is seeking a Regulatory Specialist/Compliance Specialist to join them for a Contract-to-PERM Hire engagement.

In this role you will:

  • Lead, support, and create US 510k submissions
  • Create and manage IDE filings. 21 CFR 812
  • Lead and support Notified Body review of EU Technical File
  • Help guide MDR implementation, related to theTechnical File submission
  • Support International Device Licensing and Registrations
  • Support Product Development Teams for New and or Modified, Product Submissions
  • Experience with Oncology, Radiation Therapy devices
  • Prepare Submissions to Regulatory Authorities
  • Ability to Interact and Negotiate with Regulatory Agencies regarding strategy and resolution of complex issues

 

Employer Details:

  • Onward Search is an equal opportunity employer, dedicated to a policy of non-discrimination in an employment with regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, veteran status or any other classification protected by federal, state and local laws and ordinances. Candidates must be at least 18 years old to be considered for employment. EOE/M/F/D/V/SO.
  • In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.
  • The client is unable to support 1099 / Corp-to-Corp or Independent Contractor arrangements at this time. All freelancers will be paid as W2 employees.
  • Onward Search is a drug-free workplace.
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About Onward Search

Onward Search helps connect creative, marketing, and technology talent with top jobs at the nation's most recognized companies and digital agencies. We offer a full range of recruitment and staffing solutions to include freelance / contract, temp-to-perm, and permanent placement.