Regulatory Affairs Specialist

  Regulatory Affairs

Job title: Regulatory Affairs Specialist

Company: Medtronic

Job description: Careers that Change Lives
Medtronic is the world’s largest medical technology company, offering innovative therapies to fulfill our Mission of alleviating pain, restoring health, and extending life. Medtronic is currently developing a novel kidney dialysis solution aimed at patients suffering from end-stage renal disease, and to address key infrastructural barriers, in emerging markets. As part of this initiative, Medtronic’s Renal Care Solutions group has established the Medtronic India Development Center (MIDC) in Bengaluru, and is looking to hire talented candidates to work on exciting opportunities

A Day in the Life

Collaborate and partner with Design QA, R&D, Sustaining Engineering, Clinical Affairs, Marketing and Operations. Supports the Global Operating Unit Regulatory Affairs function as the local representative for ensuring requirements are met.

Responsibilities may include the following and other duties may be assigned.

  • Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
  • Leads or compiles all materials required in submissions, license renewal and annual registrations.
  • Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
  • Monitors and improves tracking / control systems.
  • Keeps abreast of regulatory procedures and changes.
  • May direct interaction with regulatory agencies on defined matters.
  • Recommends strategies for earliest possible approvals of clinical trials applications.

Must Have: Minimum Requirements

  • Bachelor’s degree in Medical, Mechanical, Electric Life Science or other healthcare related majors
  • 5-9 years relevant experience of regulatory 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

Nice to Have

  • The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.
  • Extended periods of time doing computer-based work About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations – but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

Additional Information

  • Posting Date: May 31, 2022
  • Travel: No

Expected salary:

Location: Hyderabad, Telangana

Job date: Thu, 02 Jun 2022 04:44:36 GMT

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