Regulatory Affairs Specialist: Driving Compliance and Excellence

1 month ago

Hyderabad, Telangana, India Medtronic Full time

At Medtronic, we're shaping the future of healthcare through innovative medical technology. As a Regulatory Affairs Specialist, you'll play a critical role in ensuring our products meet regulatory requirements and exceed customer expectations.

Job Overview

We're seeking an experienced Regulatory Affairs Specialist to join our team. In this role, you'll be responsible for supporting the Global Operating Unit Regulatory Affairs function as the local representative for ensuring requirements are met.

About the Role

This is a challenging and rewarding opportunity that requires a strong understanding of regulations and policies issued by India, US FDA, and EU. You'll work closely with cross-functional teams to ensure compliance with international regulatory requirements.

Your Key Responsibilities

  • 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 to be used in submissions for assigned projects.
  • Develop Regulatory Strategies for new or modified products for assigned projects.
  • Monitor and provide information pertaining to impact of changes in the regulatory environment.
  • Communicate with regulatory agencies and/or notify bodies on administrative and routine matters.
  • Document, consolidate, and maintain oral and written communication with health authorities.
  • Prepare internal documents for modifications to devices, when appropriate.
  • Participate in health agency inspections & notified body audits as necessary.
  • Author and/or review regulatory procedures and update as necessary.
  • Review change control documents and ascertain regulatory impact for external and internal documents through formal regulatory assessments.
  • Assist in development/maintenance of regulatory files, records, and reporting systems of systematic retrieval of information.
  • Review promotional material, advertising, and labeling to ensure regulatory compliance on assigned projects.
  • Evaluate and implement new regulatory requirements affecting MEIC developed product's raw material and/or prototype.

What We Offer

We offer a competitive salary of $120,000 - $180,000 per year, depending on experience, plus a range of benefits, including comprehensive health insurance, retirement savings plan, and paid time off.

Requirements

  • Bachelor degree in Medical, Mechanical, Electric Life Science or other healthcare related majors.
  • 4-7 years experiences for RA role in medical device and/or pharmaceutical industry.
  • Good understanding for regulations and policies issued by India, US FDA, and EU, and ability to interpret international regulatory requirements.
  • Excellent written, organizational, and communication skills required, and have a flexible and team-oriented attitude.
  • Strong attention to details and ability to handle multiple tasks, good at planning, and can work under pressure.

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