Medtronic Life Science Hybrid Regulatory
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Medtronic Life Science Hybrid Regulatory Affairs Specialist Job, Apply Online

Regulatory Affairs Specialist II

Hybrid

Locations: Nanakramguda, Hyderabad, India

Time type: Full time

Posted on: Posted Today

Job Requisition ID: R17737

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life
Supporting Design and Development Control activities with regulatory requirements, direction, tactics and strategies and working in a team environment with all organizational departments.

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

  • 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 the 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 for systematic retrieval of information.
  • Review promotional material, advertising, and labeling to ensure regulatory compliance on assigned projects.
  • Ensure compliance with regulations specific to clearance and approvals of MEIC developed product’s raw material and/or prototype.

Required Knowledge and Experience

  • Bachelor degree in Medical, Mechanical, Electric Life Science or other healthcare-related majors.
  • 4-7 years of experience in an RA role in the medical device and/or pharmaceutical industry.
  • Good understanding of regulations and policies issued by India, US FDA, and EU, and the ability to interpret international regulatory requirements.
  • Excellent written, organizational, and communication skills are required, with a flexible and team-oriented attitude.
  • Strong attention to detail and ability to handle multiple tasks, good at planning and can work under pressure.
  • Good proficiency in English, including reading, writing, and speaking.
  • Good learning attitude.

APPLY ONLINE HERE

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