Regulatory Affairs Compliance Specialist

2 days ago


Étreux, Hauts-de-France, United States Meet Full time
Job Description

Meet our team and explore the opportunity to support the regulatory process as a Regulatory Affairs Compliance Specialist.

We are seeking an experienced professional to manage KPIs, generate reports, and collaborate cross-functionally to ensure compliance with global regulatory requirements.

Responsibilities:
  • Collaborate with regulatory teams (US, Canada, EMEA, APAC, LatAM) and cross-functional stakeholders to implement regulatory policies, processes, and reporting tools in alignment with business goals.
  • Support new product development, ensuring compliance with global regulatory standards.
  • Facilitate timely review and approval of product changes (e.g., ECO/DCOs) for regulatory compliance.
  • Keep up-to-date with global regulations and standards, providing regular updates and impact assessments.
  • Work with Marketing, R&D, and other teams to ensure compliant product labeling and promotional materials.
  • Maintain regulatory records and files.
  • Perform other duties to support the regulatory function.
Requirements:
  • Bachelor's degree in Life Sciences, Engineering, or related field, or equivalent experience.
  • At least 2 years of experience in Medical Device Regulatory Affairs.
  • Familiarity with US FDA 21 CFR 820, EU MDR 2017/745, and IMDRF/GHTF.
  • Proficiency in Microsoft Office, strong written and verbal communication, project management, and organizational skills.

The estimated salary range for this position is $70,000 - $100,000 per year, depending on location and experience.



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