Regulatory Affairs Specialist for Medical Devices

1 week ago

Delhi, Delhi, India beBeeSpecialist Full time ₹ 15,74,364 - ₹ 24,92,301

Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to join our team. The ideal candidate will have expertise in managing and executing regulatory strategies for medical devices, with a focus on India and neighboring countries.

Responsibilities:

  • Provide regional regulatory support to operational activities for India, including label review and collaboration with global and regional RA teams.
  • Develop and implement technical files and submissions to regulatory authorities and/or external partners within the region of responsibility.
  • Manage the continuance of regulatory compliance of existing products, including software as a medical device in selected regions.
  • Review and provide feedback on country-specific advertising, including product claims and overall direct-to-consumer content.
  • Perform region-specific due diligence on new projects, including acquisitions.
  • Support initiatives related to regional entity creations, including e-commerce.
  • Ensure timely, professional, and proactive communications with internal customers to ensure transparency of regulatory strategic plans, updates/changes, and impact to projected timeframes.
  • Monitor and maintain a high level of awareness on external standards that will influence our business through internal and external networks.
  • Accurately and timely share and recommend solutions on any potentially significant changes that will impact the business.
  • Provide post-market regulatory support and guidance as required.

Qualifications and Experience:

  • Bachelor's degree in a Life Science or Engineering-related discipline.
  • A minimum of 6 years' regulatory experience in a regional role handling regulatory work for medical devices in India and other similar entities or for other regulated products.
  • Experience in preparation and submission to India's Health Authority (CDSCO).
  • Other submission experience within similar markets is also welcomed.
  • Experience in review of marketing materials for medical devices or other regulated products.
  • Strong interpersonal communication skills in English.
  • Ability to prioritize workload and work independently by being resourceful.

What We Offer:

  • A dynamic and collaborative work environment.
  • Ongoing training and development opportunities.
  • The chance to work with a talented team of professionals.

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