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Medical Device Regulatory Specialist
hace 1 semana
About Us
We are engineers at heart, putting ambitious ideas to work to generate real solutions for real people. Our team experiments, creates, builds, improves, and solves to make tomorrow better than yesterday.
Job Responsibilities
- Comply with Medtronic policies and relevant regulations.
- Plan and organize tasks related to the preparation of document packages for regulatory submissions from regulatory affair processes.
- Lead all materials required in submissions, license renewal, and annual registrations, according to plan requirements.
- Interact with regulatory agencies on defined matters.
- Keep abreast of regulatory procedures and changes.
Requirements
- Bachelor's degree in Pharmaceutical Sciences, Industrial Engineering, or Biomedical Engineering.
- Fluent in English.
- One year of relevant experience in regulatory affairs, customer service, or technical support.
- Knowledge working with MS Office.
- Ability to work in a matrix-structured organization.
- Regulatory affairs experience and knowledge with SAP is advantageous.
