Job Description

We are seeking a Regulatory Affairs Specialist in pharmaceutical Licensing for our client in Northeast Atlanta. This Specialist will oversee compliance with regulatory requirements for medical device manufacturing and distribution. The role includes managing state pharmaceutical licenses for wholesale drug distribution, verifying client licenses, and supporting regulatory and Quality Assurance initiatives.

Our client is a pioneering medical technology company dedicated to advancing patient care through innovative solutions. With a rich history spanning over five decades, they have established themselves as a global leader in the design and manufacture of high-quality medical devices. New to the US, this is the perfect opportunity for someone who wants to work in a less-corporate culture with more autonomy and growth opportunities.

Requirements of the Regulatory Affair Specialist- Pharmaceutical Licensing:

• Bachelors degree preferred
• In-depth knowledge of FDA 21 CFR 820, ISO 13485, and NABP-VAWD regulations.
• Strong attention to detail with the ability to manage multiple compliance requirements simultaneously.
• Excellent technical writing skills for clear and concise documentation.
• Strong problem-solving, analytical, and project management abilities.
• Experience with electronic Quality Management Systems (QMS) (preferred).Regulatory Affairs certification (e.g., RAPS Medical Devices/Pharmaceuticals) (preferred).

Responsibilities of the Regulatory Affair Specialist- Pharmaceutical Licensing:

• Manage and renew state pharmaceutical licenses required for wholesale medical device distribution.
• Verify client licenses to ensure compliance with state and federal regulations.
• Ensure adherence to regulatory requirements, including:
• FDA 21 CFR Part 820
• FDA 21 CFR Part 801
• FDA 21 CFR Part 803
• FDA 21 CFR Part 806
• ISO 13485
• Track regulatory updates and communicate necessary changes to the team.
• Oversee NABP certification and inspection processes.
• Guide regulatory requirements for product labeling and distribution.
• Ensure proper reporting of adverse events and coordinate field actions in compliance with regulations.

Occupational Category: 13-1041.07 - Regulatory Affairs Specialists

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