Job opportunity for B.Pharm, M.Pharm as Medtronic looking for Regulatory Affairs Specialist-Apply before 25th January, 2024


Website Medtronic

About Medtronic

At Medtronic, we strive to provide the best possible care, therapies, and technologies to help people live longer, have less pain, and regain their health. We push each other and ourselves to improve on yesterday’s performance by tomorrow. It’s what makes being here fascinating and fulfilling. We want to develop and accelerate our capacity to produce significant ideas, but we need the proper team members to make this happen. Together, let’s meet the needs for universal healthcare and enhance the quality of life for patients. Assist us in building the future.

Post: Regulatory Affairs Specialist-II

Job Description:

Responsible for implementing regulatory compliance systems and supporting Regulatory Affairs activities at Medtronic India. This role involves active participation in all activities related to the preparation, submission, and follow-up to obtain approvals/renewals for products, variations, line extensions, and labeling approvals of medical devices across various business units. The Regulatory Affairs Specialist-II will provide technical support by interpreting federal and local regulations as they apply to products, processes, practices, and procedures.

Key Responsibilities:

  • Manage, plan, and execute the preparation, review, and submission of dossiers for product registrations, import licenses, and other approvals in compliance with regulatory requirements in India.
  • Coordinate with global regulatory teams, local business units, and other functions to develop regulatory strategies and provide documentation support for submissions in India.
  • Submit and track registration/re-registration applications with regulatory authorities.
  • Liaise with product divisions to obtain relevant details for filing changes to approved products/licenses.
  • Assess change controls through post-approval change management, ensuring regulatory compliance.
  • Monitor changes in local and global regulations, communicate updates within the department, and adhere to SOPs/systems within the organization.
  • Ensure business continuity through regulatory filings, approvals, and continuous regulatory compliance.
  • Support Marketing Teams on Tender-related issues.
  • Develop, implement, and maintain regulatory systems for document management within the department and organization.
  • Interface and coordinate with regulatory agencies/competent authorities for submissions, registrations/licenses, amendments, compliance, packaging, and quality control testing.

Candidate Profile:

  • B.Pharm/M.Pharm/Bachelor or Master’s Degree in Bio-Medical Engineering/Science discipline with training in Regulatory Affairs.
  • 5-7 years of experience in the pharma/medical device/life science industry, with at least 2-3 years of medical device experience in regulatory affairs.
  • Familiarity with various regulatory requirements for India regarding medical device registration, importclinical trials.
  • Knowledge of CDSCO, FDA, CE, and other regulatory requirements, especially in Quality Systems and Design Control.
  • Excellent communication and interpersonal skills.
  • Customer-focused with the ability to establish credibility with all levels of regulatory agencies and government bodies.
  • Self-motivated with a positive “Can do” attitude, capable of working autonomously and as a team player.
  • Strong organizational and time-management skills.

Additional Information:

  • Experience

    : 5-7 years

  • Qualification

    : B.Pharm/M.Pharm/Bachelor or Master Degree

  • Location

    : Gurgaon, Haryana

  • Industry Type

    : Pharma/Healthcare/Clinical Research

  • Functional Area

    : Regulatory Affairs

  • End Date

    : 25th January 2024

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