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Regulatory Affairs
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18000OIS Requisition #
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Title of the document Careers that Change Lives
  • Support Center of Excellence Regulatory Affairs department in product registration across Asia Pacific Region.
  • Responsible for assisting Regulatory Affairs Center of Excellence (Project Novus) in providing timely pre-market approval throughout Asia Pacific region.
  • Ensures compliance with all of the Medical Device regulations and laws pertaining to the business.


A Day in the Life


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

  • In coordination with the Asia Pacific QRA COE Manager, Project Lead & In-country Regulatory Affairs, develop effective product registration approval strategies.
  • Support the product registration process including Insight request, review & compilation of the registration in coordination of the Project Lead & In-country Regulatory Affairs.
  • Maintain internal regulatory systems, database & processes, relating to regulatory & quality such as Janus, Insight, SAP, GTS required by the business.
  • Support In-country Distributors on Product Registrations.
  • Responsible for generating a monthly report as required by the business.
  • Support in achieving assigned goals and KPIs to meet regulatory requirements and objectives
  • Work within and actively promote Medtronic’s Mission, corporate strategies, policies, procedures and Code of Conduct.
  • Other duties assigned by the Asia Pacific QRA – Center of Excellence Manager


Title of the document Must Have: Minimum Requirements
  • Bachelors degree required
  • Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience


Additional Requirements

  • Bachelor’s degree of BS Pharmacy or any bachelor’s degree
  • Minimum 3 years regulatory affairs experience required.
  • Must possess accuracy; strong attention to details; solid written and oral communication skills; ability to prioritize projects and work independently.
  • Excellent organization skills
  • Good presentation and training skills
  • Can work either autonomously or in a team
  • Experience working in an environment with global objectives.
  • “Can do” attitude
  • Aptitude for technology
  • Welcomes and embraces changes well.
  • Performing Administrative Activities – Performing day-to-day administrative tasks such as maintaining information files and processing paperwork
  • Computer literacy including sound knowledge of the MS Office Suite of software.
  • Organizing, Planning, and Prioritizing Work – Developing specific goals and plans to prioritize, organize, and accomplish your work Proven evidence of Medtronic Traits:

    • Mission Values: Consciously works to bring the Mission alive
    • External Focus: Customer responsive, competitive and market driven, leads and supports Change
    • Clear Thinking: Translates complexity into simplicity, articulates crisply and clearly
    • Driven to Win: Passionate and driven, makes tough decisions in difficult situations
    • Inspires Others: Authentic and sets a vision to inspire performance and engage others
    • Executes: Takes accountability for and consistently delivers consistent decisions, actions and results
    • Boundaryless: Breaks down silos, collaborates across organizational boundaries
    • Global: Culturally agile, strives to understand diverse market needs and responds with creative and effective solutions
    • Integrity and Compliance: Practice the highest ethical standards and integrity in every aspect of my job.


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)


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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

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