Senior Regulatory Affairs Specialist

Job Summary Responsible for independently supporting all aspects of the product labeling function necessary to ensure regulatory compliance for a variety of products (device, drug, cosmetics, etc.) and project types (labeling, marketing materials, etc.). Job Description Major Responsibilities Review, verify and complete packaging submissions to authorize label related content (packaging and collateral) based on regulations and product claims. Evaluate supporting documentation for relevant regulatory compliance. Research changes in regulations and review relevant requirements pertaining to specific products assigned (i.e. devices, drugs, cosmetics, supplements, foods) with appropriate stakeholders. Inform divisional partners of labeling and content requirements utilizing risk based approach and market knowledge. Influence change to reduce risk and improve compliance. Lead cross-functional efforts to improve overall compliance and efficiency of the department and Medline overall through ownership of process improvement initiatives, such as Kaizen projects. Conduct periodic internal audits (files, processes, databases, etc.) and maintain company/department databases, logs and files. Provide insight to improve methods to conduct appropriate level of review of historic records. Lead efforts to address compliance gaps, such as those identified through internal/external audits, by taking on full ownership of CAPA process. Train and mentor new employees, divisional QA's and product managers on regulatory product structure, regulatory labeling requirements, and Medline labeling procedure(s). Facilitate projects to improve training and on-boarding of new employees. Minimum Job Requirements Education Bachelor’s Degree or High School Diploma with extensive job experience in a field relative to the role responsibilities. Work Experience At least 4 years of experience in Quality or Regulatory Affairs for a regulated industry. Knowledge / Skills / Abilities Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook). Comprehensive knowledge and understanding of FDA product codes and product class structure, Quality Management Systems and Good Manufacturing Practices, or willingness to learn through training and independent research. Excellent communication and relationship building skills, project management, critical thinking and problem solving abilities to deliver results and meet deadlines. Preferred Job Qualifications Education Bachelor’s Degree in a science related field. Work Experience 5 years of experience in Quality or Regulatory Affairs for a regulated industry. Knowledge / Skills / Abilities Experience evaluating regulatory risk. Experience in project management using critical thinking and problem solving abilities to deliver results. Experience in evaluation of information to determine compliance with standards, laws, and regulations. 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: $92,000.00 - $138,000.00 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 roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here. 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. #J-18808-Ljbffr