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Regulatory Affairs Manager - Medical Devices

Location
Princeton, New Jersey
Job Type
Permanent
Posted
22 Sep 2022

This opportunity is with a leading pharmaceutical group dedicated to medical imaging worldwide, looking to bring on a RA Affairs Associate II (Medical Devices) to their team! This company has great work culture and opportunity for internal professional growth and development!

Description:

This is the key US regulatory role to ensure preparation, review and finalization of accurate and timely submissions of all US regulatory documents for medical devices and software driven medical devices.

  • Keep current on all US federal regulations for medical devices and software driven medical devices in order to ensure regulatory requirements and regulatory processes are understood, implemented and followed.
  • Act as internal liaison for both internal and external customers for the regulatory questions related to medical devices and software driven medical devices.
  • In partnership with the Sr. Regulatory team, participate in all interactions with US FDA pertaining to the regulatory processes for medical devices and software driven medical devices.
  • Coordinate efforts associated with the preparation, review and submission of all domestic and international regulatory documents for medical devices and software driven medical devices.
  • Identify and interpret relevant guidance documents, international standards, or consensus standards for medical devices and software driven medical devices.

Highlights:

  • Long term consulting opportunity/pathway to FTE
  • Collaborative and goal-oriented team culture
  • Exposure to global submissions of all types

Perks:

  • Full time hours
  • Immediate access to benefits (Medical, Vision, Dental)
  • 401K plan

Additional Skills & Qualifications:

  • Bachelor's degree in a scientific field is required. RAC is preferred.
  • 4 to 7 years of experience in medical device industry regulatory affairs is required.
  • Experience with maintaining a variety of regulatory affairs database systems.
  • At least 4 plus years of hands-on experience with filing required regulatory documents with the US FDA and/or appropriate government agencies.
  • Demonstrated experience with FDA interactions and understanding of regulatory processes.

Experience Level:

Intermediate

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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Details

  • Job Reference: 718901374-2
  • Date Posted: 22 September 2022
  • Recruiter: Actalent
  • Location: Princeton, New Jersey
  • Salary: On Application
  • Sector: Government & Defence
  • Job Type: Permanent