Job Opportunity at Medtronic: Regulatory Affairs Specialist

About Medtronic

Medtronic is dedicated to pushing the boundaries of technology, therapies, and services to improve patients’ lives. As a global leader in the healthcare industry, we strive to create meaningful innovations that address universal healthcare needs.

Position: Regulatory Affairs Specialist

Job Description

  • Prepare, review, file, and support premarket documents for global registrations for assigned projects.
  • Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations for assigned projects.
  • Represent Regulatory Affairs as a team member of product development projects from Concept through Commercialization.
  • Review pre-clinical and clinical protocols and associated reports for submissions.
  • Develop Regulatory Strategies for new or modified products.
  • Monitor changes in the regulatory environment and communicate relevant information.
  • Interact with regulatory agencies and/or notified bodies on administrative matters.
  • Document and maintain communication with health authorities.
  • Prepare internal documents for device modifications.
  • Participate in health agency inspections and audits.
  • Author and/or review regulatory procedures and update as necessary.
  • Review change control documents and assess regulatory impact.
  • Ensure compliance with regulatory requirements for promotional material, advertising, and labeling.

Candidate Profile

  • Bachelor’s degree in Medical, Mechanical, Electrical, Life Science, or related healthcare majors.
  • 4-7 years of experience in regulatory affairs roles in the medical device and/or pharmaceutical industry.
  • Good understanding of regulations and policies issued by India, US FDA, and EU.
  • Excellent written, organizational, and communication skills.
  • Strong attention to detail and ability to handle multiple tasks.
  • Proficiency in English (reading, writing, speaking).
  • Good learning attitude and self-motivated.
  • Ability to establish credibility with all levels of the customer base.

Additional Information

  • Experience: 1-7 years
  • Qualification: Bachelor’s degree
  • Location: Nanakramguda, Hyderabad
  • Industry Type: Pharma/Healthcare/Clinical research
  • Functional Area: Regulatory Affairs
  • End Date: 25th May 2024

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