Regulatory Affairs Specialist

2 weeks ago

Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 11,02,300 - ₹ 16,30,500
Regulatory Affairs Professional

Overview

We are seeking a skilled Regulatory Affairs professional to join our team. The ideal candidate will have expertise in regulatory compliance, technical documentation, and quality assurance.

Key Responsibilities

  • Prepare and submit regulatory documents, including technical files and product labeling, for EU and US markets.
  • Conduct gap assessments and remediation of MDD technical files to ensure compliance with EU regulations.
  • Provide regulatory support to manufacturing and R&D teams, including significant change impact assessments and change review board participation.
  • Maintain regulatory information management systems and develop procedures and templates as needed.
  • Train and guide teammates on regulatory topics and maintain annual facility registrations and device listings.

Requirements

The successful candidate will possess:

  • Strong knowledge of medical device regulations, including FDA QSR, MDSAP, ISO 13485, MDR 2017/745, and ISO 14971.
  • Experience in ophthalmology or surgical instrument field preferred, but not required.
  • Excellent analytical and problem-solving skills, with ability to assess complex technical issues.
  • Strong communication and collaboration skills to work effectively with cross-functional teams.
  • Detail-oriented and well-organized, with ability to manage multiple tasks and priorities simultaneously.

Qualifications

The ideal candidate will hold:

  • BS/BA in engineering, life sciences, or equivalent technical field.
  • MS in regulatory affairs or RA/QA certifications a plus.

Experience

The successful candidate will have at least 5 years of experience in quality or a regulated industry.

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