Regulatory Affairs Specialist
Medtronic
Karachi, Sindh, Pakistan
7d ago

Careers that Change Lives

Ensure the services of the Regulatory Affairs Department in Pakistan

A Day in the Life

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

  • Coordinate and prepare document packages for regulatory submissions and ensure the timely and accurate filing. Direct submission coordination with country regulatory agencies as needed and applicable including pre-
  • submission identification of requirements and strategy and post-submission negotiations to ensure timely approval to meet business objectives.

    Support BU for Tenders and Importation requests and requirements for the countries as assigned and all regulatory support.

    Coordinate with distributors to ensure compliance with all regulatory and quality requirements. When / where applicable supports distributors to obtain the necessary regulatory approvals and other regulatory requirements.

    Ensures compliance with the applicable local and company requirements. Ensure that submissions meet relevant external and internal requirements as applicable.

    Continuous assessment and reporting of Regulation status and Regulation changes in the assigned country. Execute strategy and follow up on action plan for countries when needed.

    Liaise and ensure effective communication and coordination with all needed stakeholders (SBU, business distributor , MOH etc.

  • Develops proficiency in any applicable regulatory requirement that applies to our products and ensures new or changed requirements are communicated within the organization.
  • Ensure full alignment in all activities with relevant department process and company SOP (i.e. order releases, documentation, etc.

    Track and report regulatory project status and informational documents appropriately. Maintain submission correspondence files and other regulatory files in a complete and secure manner for regulatory and quality compliance.

    Ensure that existing approvals and documentation are maintained as per department / company requirements. Coordinate, monitor and execute of Regulatory PMS activities including Vigilance reporting and Field Action execution within the country / is assigned when applicable.

    Provide additional support for the RA department as needed. Follow up on Quality Requests, as assigned by the department supervisor.

    Coordinate and monitor Regulatory PMS activities including Vigilance reporting (if applicable) and Field Action within the country assigned.

    Work in accordance with Work Instructions, monitor and record related documentation.

    Must Have : Minimum Requirements

    Bachelor University degree in Pharmacy Fluency in oral and written English Min 3 - 5 years of relevant professional experience in Regulatory Affairs preferably in a multinational organization Nice to Have Excellent organizational skills Computer literateGood communication skills.Ability to multitask

    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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