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Senior Regulatory Affairs Specialist VNM

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Regulatory Affairs
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18000M20 Requisition #
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Title of the document Careers that Change Lives
  • Typically, an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
  • Support Regulatory Affairs Department and all businesses including distributors in ensuring Regulatory Compliance in the areas of regulatory, government affairs, quality assurance, clinical and reimbursement
  • Participate in local Regulatory and Government Affair initiatives
  • Manage the government approval of activities such as product registration, reimbursement application to facilitate and ensure smooth and timely introduction of new products according to sales and marketing needs
  • Take initiative in local Government Affairs activities by cultivating close relationships with government agencies as needed, in order to influence and respond proactively to the development of laws and regulations governing product registration and reimbursement issues
  • Develop, in coordination with ASEAN Regulatory Affairs (RA) Senior Manager and Supervisor, effective strategies to cope with issues related to product registration, reimbursement and clinical trials


A Day in the Life


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


  • Build and maintain close relationships with related government agencies and KOLs, to establish Medtronic as an industry leader in assisting them in the formulation and implementation of fair regulations governing reimbursement and product approval. Monitor changes and feedback information regarding critical development in these regulations to Sr. Manager
  • In coordination with ASEAN Sr. Manager and local RA, develop effective product registration and reimbursement approval strategies. Directly involve in the product approval and reimbursement application process and responsible for clearing approval and reimbursement barriers and ensuring timely market release of new products, with appropriate reimbursement
  • Proactively work with the government officials and other agencies in resolving registration and reimbursement issues
  • Prepare submissions and product information changes as required by government legislation
  • Support internal systems and processes, relating to regulatory and quality, e.g. SAP, GCH etc
  • Maintain databases of all submissions and approvals
  • Provide monthly and quarterly status report including submission and approval status, regulation and reimbursement policy changes to ASEAN Sr. Manager
  • Support guidelines for product approval and processes and inform business units’ regulatory affairs staff of data necessary for inclusion in submissions
  • Support country organization’s compliance with the laws and regulations governing product registration and reimbursement
  • Coordinate and maintain product complaint handling system
  • Coordinate clinical trials and related activities
  • Responsible for coordination of product field corrective action and related activities
  • May provide guidance, coaching and training to other employees within job area.
  • May manage projects, requiring delegation of work and review of others' work product .
  • Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
  • May have practical knowledge of project management. Attributes:
    • Autonomy: Seasoned individual contributor.
    • Works independently under limited supervision to determine and develop approach to solutions.
    • Coaches and reviews the work of lower level specialists; may manage projects / processes.
    • Organizational Impact: May be responsible for entire projects or processes within job area.
    • Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
    • Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties.
    • Makes improvements of processes, systems or products to enhance performance of the job area.
    • Analysis provided is in-depth in nature and often provides recommendations on process improvements.
    • Communication and Influence: Communicates with senior internal and external customers and vendors.
    • Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.
    • May provide guidance, coaching and training to other employees within job area.
    • May manage projects, requiring delegation of work and review of others' work product.
    • Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
    • May have practical knowledge of project management.


Title of the document Must Have: Minimum Requirements
  • Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
  • Bachelor's Degree Required


Additional Requirements

  • 2 to 4 years’ experience in regulatory affairs and/or reimbursement with demonstrated experience in the full range of submissions and in dealing with local regulatory agencies
  • Work experience in a medical device or pharmaceutical industry is preferred
  • Strong computer literacy including sound knowledge of the MS Office software and MS Excel
  • Proven evidence of Medtronic Core Behaviours:
    • Customer Focus: I understand my customers’ needs and strive to exceed their expectations. I champion a customer-focused and patient centered culture across the whole company. I ensure quality in the products and services we provide.
    • Candor: I engage in honest and transparent conversations. I challenge others in constructive ways and show respect when we disagree. I encourage others to voice their perspectives.
    • Trust and Respect: I foster a diverse and inclusive work environment. I have confidence in the integrity and capability of my colleagues. I contribute to others’ success.
    • Courage: I take clear and decisive actions on difficult issues. When I take a stand, I ensure I am heard and understood. I take responsible risks and promote risk taking in others.
    • Accountability: I follow through on commitments and take responsibility for my actions. I practice the highest ethical standards in every aspect of my job. I actively support decisions made by my team.
    • Passion to Win: I operate with a sense of urgency and have a desire to win. I continually improve the quality and effectiveness of my performance. I am enthusiastic about our business and motivate others to feel the same.


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 above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.


The physical demands described within the Day in the Life 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.


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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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