Regulatory Affairs Specialist (Bogotá)

Regulatory Affairs Specialist (Bogotá)

27 may
|
Importante Empresa Del Sector
|
Bogotá

27 may

Importante Empresa Del Sector

Bogotá

At Empresa confidencial, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Empresa confidencial product or technology every 8 seconds.

As a Empresa confidencial team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.

What You Can Expect

Responsible for leading medical device labeling projects throughout the product lifecycle and ensuring compliance with integral labeling regulations as necessary to market Empresa confidencial products.



This position requires an intermediate understanding of medical devices and their use as well as an understanding of medical device labeling regulation.

How You'll Create Impact

Collaborates with cross-functional departments to create, revise and maintain labeling content that complies with global labeling regulations and requirements, including, but not limited to, Instructions for Use (IFU), information supplied to patients and medical professionals and product labels
Provides regulatory guidance on labeling requirements to cross-functional project teams to support overall regulatory strategy
Proposes and evaluates risk of regulatory labeling strategies
Collaborates with cross-functional teams to gather input, conduct reviews and approvals, and ensure accuracy and consistency in labeling content
Reviews and evaluates promotional and advertising material for compliance with applicable regulations
Ensures all labeling changes are documented and submitted in accordance with regulatory andquality manageme

📌 Regulatory Affairs Specialist (Bogotá)
🏢 Importante Empresa Del Sector
📍 Bogotá

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