Regulatory Affairs Specialist Require at Medtronic-Apply before 25th May, 2024


Website Medtronic

About Medtronic

Medtronic is a global healthcare technology company dedicated to improving the lives of people through medical innovation. With a focus on therapies and solutions that address a wide range of chronic diseases, Medtronic strives to alleviate pain, restore health, and extend life for millions of patients worldwide. From cardiac and vascular interventions to neurological and diabetes management, Medtronic’s portfolio encompasses a diverse array of medical devices, therapies, and services.

Beyond developing cutting-edge technology, Medtronic fosters a culture of collaboration and continuous improvement. By bringing together diverse perspectives and expertise, they aim to push the boundaries of what’s possible in healthcare. With a commitment to addressing universal healthcare needs and enhancing patient outcomes, Medtronic invites individuals who share their vision to join them in shaping the future of healthcare.

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 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.
  • Ensure compliance to regulations specific to clearance and approvals of MEIC developed product’s raw material and/or prototype.

Candidate Profile:

  • 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 are 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.
  • Proficiency in English, including reading, writing, and speaking.
  • Good Learning attitude.
  • Excellent communication and interpersonal skills.
  • Self-motivated and positive.
  • Ability to quickly establish credibility with all levels of customer base.

Additional Information:

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