Wastewater Project Engineer

10 hours ago


Bloomfield Hills, Michigan, United States Entegee Full time
Job Description

Regulatory Affairs Specialist

Ensures company products comply with regulatory requirements and standards for safety and efficacy.

Key Responsibilities:

  • Prepares, reviews, and submits regulatory documents to FDA and other global health authorities.
  • Monitors and interprets regulatory developments, communicating potential impact to the team.
  • Provides regulatory guidance throughout the product lifecycle, from development through post-market.
  • Manages and maintains regulatory timelines to ensure timely submissions and approvals.
  • Coordinates with cross-functional teams to ensure compliance with regulatory requirements.

Preferred Skills:

  • Advanced degree in life sciences or a related field.
  • Experience with electronic submission platforms (eCTD).
  • Knowledge of regulatory pathways for new drug applications in the EU, Japan, and other international markets.

Benefits:

  • Medical, dental, vision, life insurance, short-term disability, and additional voluntary benefits.
  • 401K plan and commuter benefits.

Equal Opportunity Employer/Veterans/Disabled



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