Regulatory Affairs Specialist

Position: Regulatory Affairs Specialist

Location : Tempe, AZ

Duration : 12+ Months contract

Total Hours/week: 40.00

1st Shift

Client: Medical Device Company

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

Must haves on the resume: detail oriented, flexible, technical writing

“For many roles at this client, assignment is contingent upon the Employer of Record’s receipt of sufficient proof that you are fully vaccinated against COVID-19 (meaning two weeks have passed after the last injection of Pfizer/Moderna or two weeks after receipt of the J&J). In some locations, weekly testing for COVID-19 may be available instead of vaccination. Requests for accommodation will be considered pursuant to applicable law.”

The Regulatory Affairs Specialist is responsible for product remediation projects, process and systems remediation projects, and the preparation of regulatory submissions required to legally market medical devices in the European Union under the MDR. This role will provide support for global product registrations and related regulatory affairs activities, as the need arises. The candidate must have demonstrable in-depth knowledge of preparing a submission, applying relevant regulations and statutes to further product submissions of basic to medium complexity, and translating technical data and descriptions into reviewer-friendly content. Additionally, the candidate will interact with regulatory bodies to help further product approvals or clearance. This role will appropriately execute project activities based on applicable products and systems which are designed to ensure that the product development process adheres to all regulatory requirements as well as objectives to the business. The candidate must be able to manage change and be flexible when providing solutions as well as work independently with minimal guidance while determining own work priorities. The candidate will be expected to collaborate with their regulatory team and cross functional team members to build strong and effective working relationships and act as a resource for colleagues with less experience.

This position requires a Bachelor’s degree or advanced degree in a technical area such as biology, chemistry, engineering or medical-related field.
4+ years employment in Regulatory Affairs, areas of product registration, compliance, or quality systems is preferred.
Experience with European Medical Device Regulations is preferred.