Job Title: Senior Regulatory Affairs Specialist
Location: Hybrid, Bogotá, Colombia
Time Type: Full Time
Posted On: 5 Days Ago
End Date to Apply: May 19, 2025
Job Requisition ID: R27902
Job Description
At Medtronic, embark on a life-long career of exploration and innovation, contributing to improved global healthcare access and equity. Join us in leading with purpose and driving forward a compassionate, connected world.
A Day in the Life
As a Senior Regulatory Affairs Specialist, you will lead the coordination and preparation of documentation for regulatory submissions, oversee internal audits, and ensure full regulatory compliance. This hybrid position is based in Bogotá, Colombia.
Key Responsibilities
Lead or support the preparation of comprehensive document packages for regulatory submissions across all business areas.
Direct internal audits and respond to inspections with regulatory documentation.
Manage the compilation of materials for license renewals and annual registrations.
Recommend changes in labeling, manufacturing, marketing, and clinical protocols to ensure regulatory compliance.
Improve and maintain tracking and control systems for regulatory processes.
Stay current with evolving regulatory requirements and procedures.
Interact directly with regulatory agencies on defined matters.
Strategize for the fastest possible approval of clinical trial applications.
Required Qualifications
Bachelor’s degree in a relevant discipline.
Minimum of 4 years of experience in regulatory affairs or regulatory operations.
Fluency in English (verbal and written).
Proficiency in Microsoft Office (Outlook, Excel, Word, PowerPoint).
Demonstrated global mindset and growth orientation.
Comfortable working in a matrix-structured organization.
Experience with SAP and GTS is considered advantageous.
Physical Job Requirements
This description outlines the general scope of responsibilities associated with the role but is not an exhaustive list of tasks or skills required.
Benefits & Compensation
Competitive salary structure.
Flexible benefits package designed to support all life and career stages.
This role is eligible for the Medtronic Incentive Plan (MIP), a short-term performance-based bonus program.
We recognize and reward your contributions and offer opportunities for personal and professional growth.
About Medtronic
Medtronic is a global leader in medical technology, improving lives through bold ideas and compassionate solutions. With over 95,000 employees worldwide, our mission is to alleviate pain, restore health, and extend life. We unite talent and innovation to deliver real solutions across more than 40 health conditions affecting millions of lives each year.
Slug: Senior-Regulatory-Affairs-Specialist-Colombia
Job Title: Senior Regulatory Affairs Specialist
Location: Hybrid, Bogotá, Colombia
Time Type: Full Time
Posted On: 5 Days Ago
End Date to Apply: May 19, 2025
Job Requisition ID: R27902
Job Description
At Medtronic, embark on a life-long career of exploration and innovation, contributing to improved global healthcare access and equity. Join us in leading with purpose and driving forward a compassionate, connected world.
A Day in the Life
As a Senior Regulatory Affairs Specialist, you will lead the coordination and preparation of documentation for regulatory submissions, oversee internal audits, and ensure full regulatory compliance. This hybrid position is based in Bogotá, Colombia.
Key Responsibilities
Lead or support the preparation of comprehensive document packages for regulatory submissions across all business areas.
Direct internal audits and respond to inspections with regulatory documentation.
Manage the compilation of materials for license renewals and annual registrations.
Recommend changes in labeling, manufacturing, marketing, and clinical protocols to ensure regulatory compliance.
Improve and maintain tracking and control systems for regulatory processes.
Stay current with evolving regulatory requirements and procedures.
Interact directly with regulatory agencies on defined matters.
Strategize for the fastest possible approval of clinical trial applications.
Required Qualifications
Bachelor’s degree in a relevant discipline.
Minimum of 4 years of experience in regulatory affairs or regulatory operations.
Fluency in English (verbal and written).
Proficiency in Microsoft Office (Outlook, Excel, Word, PowerPoint).
Demonstrated global mindset and growth orientation.
Comfortable working in a matrix-structured organization.
Experience with SAP and GTS is considered advantageous.
Physical Job Requirements
This description outlines the general scope of responsibilities associated with the role but is not an exhaustive list of tasks or skills required.
Benefits & Compensation
Competitive salary structure.
Flexible benefits package designed to support all life and career stages.
This role is eligible for the Medtronic Incentive Plan (MIP), a short-term performance-based bonus program.
We recognize and reward your contributions and offer opportunities for personal and professional growth.
About Medtronic
Medtronic is a global leader in medical technology, improving lives through bold ideas and compassionate solutions. With over 95,000 employees worldwide, our mission is to alleviate pain, restore health, and extend life. We unite talent and innovation to deliver real solutions across more than 40 health conditions affecting millions of lives each year.
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
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Mitte |Brandenburg :
Berlin |Germany :
Germany | GErmany |Hesse :
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Frankfurt | Harveysburg |Lower Saxony :
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Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
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Halle |Schleswig Holstein :
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Bulgaria |Denmark :
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France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Brinny | Ringaskiddy |County Dublin :
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Galway |Meath :
Dunboyne |Republic of Ireland :
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Donegal |China :
China | Quarry Bay |Hubei :
Wuhan |Liaoning :
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Hangzhou |Melbourne :
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Ballina | Sydney |Queensland :
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Remote Australia |Republic of Western Australia :
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Amsterdam |Netherlands :
Netherlands |Noord Holland :
Haarlem |North Brabant :
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Leiden |North Yorkshire :
Harrogate |Oxfordshire :
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Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Austria |Vienna :
Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
Mississauga | North York | Renfrew | Uxbridge | Richmond Hill |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
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Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Chuuk :
North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Paris | Lyon |Attica :
Athens | Koropi |Greece :
Greece |East Java :
Surabaya |Jakarta :
Jakarta |Israel :
Kfar Saba | Yavne | Tel Aviv | Be'Er Sheva | Netanya |Italy :
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Rho |Japan :
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Almaty |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kuala Lumpur :
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Ciudad de México |North Island :
Auckland |Lima Region :
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Manila |Mazovia :
Warsaw |Remote :
McFarland | Remote | Melbourne | Remote - South America (Latin Americal) | Remote - Africa | Remote, USA | Remote - Europe | Victoria | Lenexa | Switzerland | Remote - Middle East |Bucharest :
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King Abdullah Economic City | Khulais | Rabigh | Riyadh | Jeddah | Najran |Nišava District :
Niš |Singapore :
Singapore |South Africa :
Midrand | South Africa |Brazil :
Brazil | Sao paulo |South America :
Peru | Argentina |Catalonia :
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Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
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Kyiv |Dubai :
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Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |