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Regulatory Affairs Manager

3 months ago

Norwood, United States BioTalent Full time

Introduction

BioTalent is representing a top-tier life sciences device manufacturer hiring a Regulatory Affairs Manager ensure compliance with global regulatory requirements while managing the regulatory affairs team. The role requires collaboration with product development, quality assurance, and other cross-functional teams to support the organization's goals.


This role will offer you

  • Lead an existing team across three sites while adding headcount.
  • Work on cutting edge technology found globally.
  • Industry leading benefit packages.


You will be responsible for

  • Develop and implement regulatory strategies to ensure timely approvals of new and existing products.
  • Manage and maintain product registrations, licenses, and regulatory compliance globally.
  • Serve as the primary contact with regulatory agencies, including the US FDA, Notified Bodies, and other international entities.
  • Oversee the preparation of regulatory submissions, ensuring accuracy and compliance with all regulatory requirements.
  • Ensure regulatory compliance throughout the product lifecycle, including post-market surveillance.


You will bring the following

  • Minimum 5-7 years of IVD regulatory compliance submissions experience supporting Class I and Class II medical devices.
  • Experience with EU IVD Regulation/Directive and quality system standards.
  • Strong organizational, written and verbal communication skills