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Regulatory Affairs
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19000D3U Requisition #
Careers that Change Lives
  • Ensures compliance with all of the Medical Device regulations and laws pertaining to the business
  • Ensures customer satisfaction with timely, efficient, and accurate service.


A Day in the life


Responsibilities may include the following and other duties may be assigned

    Key Accountabilities:
    • In coordination with the RA Manager, develop effective product registration approval strategies. Directly involved in the product approval process and responsible for clearing approval and other barriers to ensure timely market release of new products with appropriate licenses.
    • Facilitate the product registration submissions of Medtronic products for initial registration, renewal, compliance, special requests and other related concerns.
    • Facilitate the review and registration of Product Change Notification
    • Facilitate the registration of Licenses and ensures the validity and compliance with the requirements of Philippine Food and Drug Administration
    • Monitors Certificates, Licenses, Legal Documents and ensures that they are up to date.
    • Proactively work with external regulatory agencies during registration process
    • Maintain database of all submissions and approval such as JANUS.
    • Support internal systems and processes, relating to regulatory & quality such as Change Notifications, SAP, GTS, GCH & etc.
    • Obtain export certificates and prepare notarization/legalization of these documents
    • Provide Distributor’s requirements during government tenders & hospital inclusions.


    Attributes:

    • Must possess accuracy; strong attention to detail; solid written and oral communication skills; ability to prioritize projects and work independently; and excellent organizational skills
    • Experience working in an environment with global objectives


Must Have: Minimum Requirements
  • Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
  • Bachelor's Degree Required


Additional Requirements

  • Performing Administrative Activities - Performing day-to-day administrative tasks such as maintaining information files and processing paperwork
  • Communicating with Supervisors & team members - Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person
  • Organizing, Planning, and Prioritizing Work - Developing specific goals and plans to prioritize, organize, and accomplish your work
  • Proven evidence of Medtronic Leadership Traits:
    • Shape- Demonstrates global business acumen, thinks critically and makes sound decisions, sets strategic direction
    • Engage- Collaborates and creates alignment; attracts, deploys, and develops talent; fosters diversity and inclusion
    • Innovate- Focuses on patient and customer, generates breakthrough ideas, initiates and leads change
    • Achieve- Sets high standards, instills operational excellence, drives accountability, models ethical behavior
  • Minimum 2 years regulatory affairs experience required
  • Bachelor’s degree of BS Pharmacy or any bachelor’s degree
  • Knowledgeable of FDA guidelines for Medical Devices.


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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