Regulatory Affairs Specialist for Medical Devices and Global Markets

3 days ago


Ahmedabad, Gujarat, India Alpine Health Full time

Company Overview:

Alpine Health, a licensed pharmaceutical distributor based in New Jersey, USA, serves independent pharmacies across the US with a wide range of products including generics, OTCs, and medical devices. Founded in 2008, the company has expanded its reach globally, partnering with international companies to introduce high-quality medical devices worldwide.

Salary: $80,000 - $110,000 per annum

Job Description:

This is an exciting opportunity to work in a key role with diverse responsibilities in a growing healthcare company that has expanded across various domains in the industry. As a Regulatory Affairs Specialist, you will contribute to the growth of the company by building strong medical device portfolios in regulated markets worldwide.

Your primary focus will be on coordinating successful submissions and approvals of medical device applications with regulatory authorities globally. You will also be responsible for keeping up-to-date with changes in regulatory legislation and guidelines for medical devices, ensuring compliance with international standards.

Key Responsibilities:

  • Coordinate regulatory submissions and approvals with various global regulatory authorities
  • Stay updated on regulatory changes and ensure compliance with international standards
  • Develop and maintain comprehensive product information leaflets and labels
  • Review and report quality status to management
  • Provide technical expertise and guidance on regulatory requirements

Required Skills and Qualifications:

To succeed in this role, you will need:

  • An advanced degree (MS) in a relevant field; a Bachelor's Degree in Bio-medical engineering is required
  • A minimum of 5 years' experience in regulatory affairs and product registrations
  • Proven knowledge of regulatory submission and approval processes for medical devices
  • Excellent communication and teamwork skills

Benefits:

We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development in a dynamic and expanding organization.



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