Intellectt Inc

Regulatory Affairs Specialist 

Intellectt Inc Mansfield, MA
Intellectt Inc

Regulatory Affairs Specialist 

Intellectt Inc Mansfield, MA
2 months ago 40 applicants

See who Intellectt Inc has hired for this role

Hi, This is Harsha from Intellectt Inc. our medical device clients were in search of Regulatory Affairs Specialist in Mansfield, MA - 2048. if you are intrested please share me your updated resume to harsha@intellectt.com or give me a call back at +1 732-276-1830

Role: Regulatory Affairs Specialist

Location: Mansfield, MA - 2048

Duration: 8 Months

Essential Duties And Responsibilities

  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

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

    Contract

  • Job function

    Legal

  • Industries

    Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing

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