Top 1 Regulatory affairs specialist Jobs in Lafayette Co

Regulatory Affairs Specialist II
Zimmer Biomet —Englewood, CO
- $60,000 - $90,000 a year
- Full-time
- Microsoft Outlook
- Mid-level
- Office
- Wellness program

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Regulatory Affairs Specialist II
Zimmer Biomet —Englewood, CO
Bachelor’s degree in a technical field (Engineering, Biology, or Regulatory Science) and 3-7 years of regulatory experience; or equivalent combination of…
$60,000 - $90,000 a year

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Regulatory Affairs Specialist II

Zimmer Biomet -
Englewood, CO

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Job Details

Full-time
$60,000 - $90,000 a year

Benefits

Wellness program

Qualifications

Biology
FDA submissions
Microsoft Outlook
Labeling
Safety regulations
Product launch management
Compliance audits & assessments
Filing
Collaborating with government agencies
GMP
Mid-level
3 years
Quality control audit
Bachelor's degree in biology
Regulatory legal research
Client database systems
Quality assurance audits
Collaboration with product development teams
Bachelor's degree in engineering
System validation
Organizational skills
Technical writing experience
Regulatory submission editing and review
Biomedical regulatory compliance
Document quality checks
Technical writing quality assurance
Quality audits
Customer information system software
Legal compliance
Leadership

Full Job Description

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

Fuel the Future of Foot and Ankle Innovation!

Paragon 28 (a Zimmer Biomet company) is on a mission to redefine orthopedic care for the foot and ankle. We are looking for a high-energy Regulatory Affairs Specialist II to help launch our cutting-edge medical devices into global markets. This position will be based out of our location in Englewood, Colorado.

If you are a proactive problem-solver who thrives on collaboration, navigating global compliance, and turning complex regulations into successful product launches, we want you on our team!

Your Impact

Drive Global Strategy: Craft and execute winning regulatory strategies for the US, Canada, and expanding international territories.
Lead Submissions: Own the lifecycle of critical submissions and maintain direct, professional communication with major government agencies like the FDA and Health Canada.
Cross-Functional Collaboration: Partner daily with brilliant minds in Engineering, Quality, and Regulatory Affairs to bring life-changing devices from concept to market.
Champion Quality: Act as a gatekeeper for safety and compliance by performing vital regulatory assessments and quality system reviews.

What You Bring

Masterful navigation of FDA and Health Canada regulations.
Experience writing and managing successful medical device submissions.
Strong collaboration skills to bridge the gap between engineering innovation and regulatory compliance.
A sharp eye for detail when auditing quality management system documents.

Ready to accelerate your career with an industry leader? Apply today and step into a role where your work directly improves patient mobility worldwide!

How You'll Create Impact

Review and understand global regulatory requirements (FDA, TGA, EU MDD, EU MDR, Health Canada, etc.)
- Maintain compliance to FDA UDI requirements
Assemble and maintain regulatory files (510(k) submissions, STED, Technical Files, etc.)
- Assist engineering in implementing verification and validation strategies
- Work with regulators to release products into new or established markets
- Review and establish predicates for FDA premarket notifications
- Review competitive literature to develop regulatory strategies
- Support project teams in decisions that affect regulatory compliance
Review marketing literature for regulatory compliance
Registration and listing of devices
Create and maintain product labeling
Knowledge of GMPs
Other duties as assigned

Your Background

Bachelor’s degree in a technical field (Engineering, Biology, or Regulatory Science) and 3-7 years of regulatory experience; or equivalent combination of education and experience.
Knowledge of 21 CFR Part 820, EU MDD 93/42/EEC, EU MDR 2017/745, and ISO 13485
Understanding of orthopedic and/or implantable devices; previous medical device industry experience required
History of working collaboratively across functions
Excellent attention to detail and proven organizational skills, able to prioritize and multi-task and see projects/assignments to completion
Proficiency in Excel, Word, PowerPoint, Outlook and customer database management systems
Proficiency with FDA’s eSTAR submission tool
Proven leadership and negotiation skills, works well with all levels, able to successfully manage cross-departmental expectations
Excellent written and verbal communication skills

Travel Expectations

10% of overnight travel.

Compensation Data

Salary Range: $60,000 - $90,000 USD Annually

EOE

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Regulatory Affairs Specialist II

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