Senior Regulatory Labeling Specialist

Medline•Northfield, MN

19h

About The Position

Responsible for independently supporting all aspects of the product labeling function necessary to ensure regulatory compliance for a variety of product (device, drug, cosmetics, etc.) and project types (labeling, marketing materials, etc.).

Requirements

Bachelor’s Degree or High School Diploma with extensive job experience in a field relative to the role responsibilities
At least 4 years of experience in Quality or Regulatory Affairs for a regulated industry.
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.

Nice To Haves

Bachelor’s Degree in a science related field.
5 years of experience in Quality or Regulatory Affairs for a regulated industry.
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.

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.