Regulatory Affairs Director: Global Healthcare Leader

3 days ago


Pune, Maharashtra, India Lifelancer Full time

Job Overview

Lifelancer, a leading talent-hiring platform in Life Sciences, Pharma and IT, is seeking an experienced Director of Regulatory Affairs to lead our Image Guided Therapy Systems Mobile Surgery (IGTS MoS) Category. As a critical member of the IGTS MoS Leadership Team, you will drive regulatory strategy and compliance across the globe.

About the Role

  • You will oversee the development and execution of global regulatory strategies and policies for the IGTS MoS business, ensuring compliance with worldwide regulations.
  • Lead a high-performing team of Regulatory Affairs professionals, providing guidance and mentorship on global compliance, product registrations, and clinical evaluations.
  • Partner with cross-functional teams to understand patient and market needs, driving innovation and new product introductions.
  • Develop processes and procedures to ensure an effective Quality System, maintaining quality and regulatory compliance.
  • Represent Regulatory Affairs in activities concerning mergers and acquisitions, ensuring seamless integration and compliance.

What We Offer

  • A competitive salary range of $180,000 - $250,000 per year, depending on experience.
  • The opportunity to work with a talented team and contribute to the success of Lifelancer.
  • A dynamic and fast-paced environment with opportunities for growth and professional development.

Requirements

  • A Master's Degree in a Life-Sciences discipline or Regulatory/Quality/Health-related discipline.
  • Minimum 15+ years' experience in Regulatory Affairs within medical device/technology environments, with 8+ years as a functional leader.
  • Strong track-record successfully leading Regulatory Affairs teams, bringing products to market on time.
  • Extensive knowledge of FDA and other regulatory submissions, Design Controls, MDD, MDR, MedDev's, ISO 13485 & 14155, and applicable major/regional worldwide regulations.

About Lifelancer

We are a health technology company dedicated to improving access to quality healthcare worldwide. Our mission is to connect talent with opportunities in pharma, biotech, health sciences, healthtech, and IT domains.



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