Regulatory Affairs Specialist in Tempe, AZ at Integrated Resources, Inc

Date Posted: 5/16/2021

Job Snapshot

  • Employee Type:
    Full-Time/Part-Time
  • Location:
    Tempe, AZ
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    5/16/2021

Job Description

Title: Regulatory Affairs Specialist.

Location – Tempe, AZ 85281

Duration – 12 months

Job Description:-

  • Must be local - due to COVID restrictions, position would start as remote; however, once these restrictions lifted, expectation would be at least part time onsite
  • 3 Must haves on the resume: detail oriented, flexible, technical writing.
  • The Regulatory Affairs Senior 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.

Qualification:-

  • 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.
#zr1