Regulatory Affairs Lead

1 month ago


Ahmedabad, Gujarat, India Lifelancer Full time

About the Role:

We are seeking a highly skilled Regulatory Affairs Specialist to provide direct Worldwide Regulatory support to various projects and products. As a key member of our team, you will be responsible for supporting strategic planning and product development efforts, and providing Regulatory support for existing products with respect to product changes/modifications, labeling, and promotional material review and approval.

  • Key Responsibilities:
  • Write, coordinate, and complete the submission of Regulatory documents to the FDA and other Regulatory agencies (e.g., EPA). Includes international documents (e.g., tech files).
  • Prepare responses to FDA questions and other Regulatory correspondence.
  • Provide direct Regulatory support to project teams including the creation of detailed Regulatory Plans.
  • Conduct product labeling and advertising review and approvals.
  • Evaluate proposed product modifications for Regulatory impact. Complete Regulatory Assessments as needed.
  • Manage an internal team of resources working on different regulatory-related client projects.
  • Liaison between client Program engagement manager and Hops Healthcare delivery execution team for assigned projects.

Requirements:

To succeed in this role, you will need:

  • A minimum of 1-3 years of experience in Regulatory Affairs, preferably in the medical device industry.
  • Excellent communication skills, both verbal and written.
  • Good organizational skills.
  • Good analytical thinking, problem-solving, and investigative skills.
  • Knowledge of Medical Device Regulatory, FDA regulations, CE and ISO.

What We Offer:

We offer a competitive salary of $85,000 - $110,000 per year, depending on experience, plus benefits and opportunities for professional growth and development.



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