Regulatory Affairs Specialist
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The Opportunity
Description
We're looking for a Regulatory Affairs Specialist, working in Biotechnology/Medical Devices industry in Louisville, Colorado, United States.- Implements regulatory strategies for new technologies and product modifications, considering both domestic and international regulations.
- Provides regulatory affairs support to cross-functional teams and sustaining engineering.
- Designs History File documentation and adherence to FDA/QSR design control requirements.
- Maintains current regulatory knowledge of domestic and international regulations, guidelines, and standards.
Our Client
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
- Bachelors degree with 2+ years of medical device experience and work experience in regulatory affairs, or Masters degree with 0+ years of medical device experience and work experience in regulatory affairs
- Familiarity with regulatory requirements in major international markets
- Working knowledge of IEC 60601-series standards
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?
