Regulatory Affairs Specialist
13 hours ago
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.
Job Description
Major 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.
Education
- 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.
Certification/Licensure
- 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%
Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
The anticipated salary range for this position:
$79,560.00 - $115,440.00 Annual
The actual salary will vary based on applicant's location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.
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 a more comprehensive list of our benefits please click here. 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.
We're dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.
Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.
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