Regulatory Affairs Assoc Specialist - Bogotá, Colombia - Zimmer Biomet

Descripción

At Zimmer Biomet, 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 Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet 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 recognized.

What You Can Expect

Responsible for assisting the team with regulatory filings as necessary to market Zimmer Biomet products. This is an entry level position, providing training towards full competency in Regulatory Affairs (RA). This position requires a basic understanding of medical devices and their use as well as a basic understanding of the regulatory submissions process in Colombia and Latin America. May perform some or all of the following functions, depending on specific assigned focus.

How You'll Create Impact

• Coordinate and assist in the preparation of technical documentation for use in regulatory submissions for product registrations, renewals and registration changes
• Assist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products
• May aid in regulatory direction to development project teams as a core team member; supports regulatory strategy for new products
• Reviews proposed labeling and package inserts for compliance with applicable international and country regulations
• Maintains registration databases, product registration records, key performance indicators current, and communicates approved registrations.
• Assist in the review and evaluation of promotion and advertising material for compliance with applicable regulations
• Supports and reviews proposed product changes for impact on regulatory status of the product
• Follows Zimmer Biomet RA policies and procedures
• Miscellaneous responsibilities as assigned

What Makes You Stand Out

• Strong writing, communication, and interpersonal skills
• Strong attention to detail
• Strong problem-solving and analytical skills
• Ability to work with rapid changes; flexible and able to balance competing priorities
• Ability to learn and apply regulations pertinent to medical devices, biologics, drugs and combination products, specific to the product registration process in Latin America
• Self-motivated and capable to work in a diverse, fast-paced and dynamic environment
• Ability to build strong relationships; communicate effectively at all levels
• Basic computer skills, including Microsoft Office Suite

Your Background

• Bachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field preferred
• Intermediate English Proficiency is required, Portuguese is preferred.
• Limited regulatory submission preparation experience a plus

Travel Expectations

Up to 10%

EOE/M/F/Vet/Disability