Regulatory Operations Expert
hace 5 días
Job Summary
We are seeking a highly skilled Senior Regulatory Operations Specialist to join our team at COS Medtronic Shared Services Americas S.A.S. in Colombia.
About the Role
This is a remote-based position that requires collaboration with internal teams to drive process improvements, implement GTS strategies, and support transformational projects. As a Senior Regulatory Operations Specialist, you will be responsible for preparing, publishing, and delivering regulatory submissions, including initial large marketing authorization applications and electronic common technical documents (e-CTD).
Responsibilities
- Preparation and Publication of Regulatory Submissions: Ensure the quality control and delivery of paper and electronic components of all submissions, including initial large marketing authorization applications and e-CTD.
- Enterprise-Wide Regulatory Management Systems Support: Assist in coordinating, training others, developing plans, and providing input to systems designs.
- Process Improvement: Conduct continuous efficiency and effective process improvement measurements to evaluate external vendors.
- Paper and Electronic Submissions Preparation: Prepare, submit, track, index, and archive paper and electronic submissions, including information, amendments, annual reports, general correspondence, adverse event reporting, and promotional materials.
Requirements
- Education and Experience: Bachelor's degree with five years of experience in regulatory affairs or related areas.
- Languages and Skills: Fluent in English, proficient in Microsoft Office (Outlook, Excel, Word, PowerPoint), and ability to transform knowledge into solutions (automations/digitization). SAP and GTS experience is advantageous.
Compensation and Benefits
We offer a competitive salary and flexible benefits package. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our mission unites a global team of passionate people to alleviate pain, restore health, and extend life.
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