Regulatory Affairs Specialist

Medline • Northfield, MN

10d

About The Position

Under general supervision, works to ensure products and processes meet all applicable state, federal, local regulations, and industry best practices for distribution of regulated products, food, pharmaceuticals, or medical devices.

Requirements

• Bachelor’s Degree (regulatory field, biology, chemistry, engineering, pharmacology, quality, toxicology).
• At least 2 years of experience in regulatory, quality assurance, scientific affairs, pharmaceutical operations, or related area.
• Experience applying an understanding of the current Regulatory environment and demonstrating the ability to perform within.
• Experience evaluating information to determine compliance with standards, laws, and regulations.
• Exceptional attention to detail and analytical skills to interpret complex regulations.
• Advanced skill level in SAP or other Enterprise Resource Planning (ERP) systems.
• Advanced skill level in Excel and Word.

Nice To Haves

• GDP/GMP requirements for distribution of regulated products (food, drugs, devices)
• Experience in regulatory distribution requirements
• Experience creating/implementing SOPs.
• Experience applying knowledge of the CFR, FDA, EPA, CPSC guidelines.
• Experience managing compliance activities
• Travel up to 25%

Responsibilities

• Monitor regulatory changes and interpret their impact on the distribution center's operations.
• Develop, implement and manage internal policies and programs to ensure compliance with laws and regulations. This includes best practices for GDP such as temperature monitoring, pest control, etc.
• Conduct regular audits to identify potential weaknesses and non-compliance
• Respond to stakeholders and regulatory agencies for regulatory distribution compliance
• Engage with stakeholders and participate in cross-functional projects to ensure continuous compliance of distribution of products.
• Maintain and update regulatory database tracking systems for compliance.

Benefits

• Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
• Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average.
• For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees