Regulatory Affairs Specialist

2 days ago

Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 30,00,000 - ₹ 45,00,000
Job Description

As a Regulatory Affairs Specialist, you will play a critical role in ensuring medical devices comply with regulatory requirements.

  • Develop and manage document packages for regulatory submissions and renewals, focusing on EU Technical Files, MDSAP, and other regulated countries.
  • Author Technical file documentation to support EU MDR requirements, reviewing product labeling for regulatory compliance.
  • Contribute to complaint handling processes and prepare/submits MDRs and Incidents to appropriate health authorities.
  • Perform MDR gap assessments and remediation of MDD technical files, providing regulatory support to manufacturing and R&D teams.
  • Develop and maintain Regulatory Information Management systems and co-author regulatory plans for new product introductions or product line extensions.
Required Skills and Qualifications

In-depth knowledge of medical device regulations and standards, such as FDA QSR, MDSAP, ISO 13485, (EU) MDR 2017/745, and ISO 14971 is required. Experience in Ophthalmology or surgical instrument fields is preferred, along with experience in medical device development, quality assurance, or regulatory affairs.

  • Strong analytical and problem-solving skills, with excellent communication and collaboration abilities to work effectively with cross-functional teams.
  • BS/BA in Engineering, Life Sciences, or an equivalent technical field is mandatory. MS in Regulatory Affairs or RA/QA certifications are a plus.
  • 5-8 years of experience in Quality or a regulated industry is preferred.
About the Role

This role offers a unique opportunity to contribute to the success of our organization by ensuring regulatory compliance and driving business growth.

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