Regulatory Affairs Specialist

hace 2 semanas

Bogotá Cundinamarca, Colombia Zimmer Colombia A tiempo completo

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 talented 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 inspired, invested, cared for, valued, and have a strong sense of belonging.

**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 understanding of medical devices and their use as well as a basic understanding of the regulatory submissions process in different countries. May perform some or all 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.
- Maintains registration databases, product registration records, key performance indicators.
- Assist in the review and evaluation of promotion and advertising material for compliance with applicable regulations
- Follows Zimmer Biomet RA policies and procedures.
- Gather Technical and Legal documents for Global submissions.
- Miscellaneous responsibilities as assigned

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

**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.
- 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, or related field preferred.
- 3 Years of Experience
- Advanced English Proficiency is required

**Travel Expectations**:
Up to 10%

EOE/M/F/Vet/Disability

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