Intellectt Inc hiring Regulatory Affairs Specialist in Mansfield, Massachusetts, United States | LinkedIn (2024)

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Intellectt Inc hiring Regulatory Affairs Specialist in Mansfield, Massachusetts, United States | LinkedIn (2)

Regulatory Affairs Specialist

Intellectt Inc Mansfield, MA

Intellectt Inc Mansfield, MA

2 months ago 35 applicants

Intellectt Inc hiring Regulatory Affairs Specialist in Mansfield, Massachusetts, United States | LinkedIn (4) Intellectt Inc hiring Regulatory Affairs Specialist in Mansfield, Massachusetts, United States | LinkedIn (5) Intellectt Inc hiring Regulatory Affairs Specialist in Mansfield, Massachusetts, United States | LinkedIn (6)

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Role: Regulatory Affairs Specialist IIILocation: Mansfield, MA - 2048Duration: 8 Months Primary Responsibilities Are To

  • Serves as the Regulatory Affairs lead on cross-functional MDR project teams
  • 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 schedule.
  • Collaborates with the cross-functional team to respond to requests from the EU Notified Body during the MDR technical documentation review.
  • Prepares regulatory strategy to globally communicate and assess changes in scope of MDR project
  • Helps provide solutions to problems of moderate scope and complexity.

DESIRED MINIMUM QUALIFICATIONS

  • 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.

TOOLS AND EQUIPMENT USED

  • Normal office environment: must be computer literate and familiar with Microsoft Suite of Products including Word, Excel, Outlook or similar.

  • Seniority level

    Associate

  • Employment type

    Full-time

  • Job function

    Legal

  • Industries

    Staffing and Recruiting

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