Regulatory Affairs Specialist

4 weeks ago


Northbrook, Illinois, United States Medline Full time

Job Summary

The Regulatory Affairs Specialist will be responsible for planning and executing state and federal regulatory activities necessary for Chemical Compliance of our products. This includes preparing comprehensive Chemical Compliance regulatory strategies for new products markets, and post-market product changes, ensuring that the content, context, organization, and quality of supporting information is sufficient to meet all regulatory requirements, commitments, and agreements.

Key Responsibilities

  • Review complex regulatory issues with RA management and other team members by applying their specialized experience to solve issues and complete short-term department goals
  • Determine the requirements for completing and maintaining product chemical requirements
  • Recommend regulatory pathways and strategies
  • Review and provide feedback on documentation and supporting evidence to ensure applicable regulatory requirements are met
  • Complete and maintain regulatory filings by collaborating with internal and external groups, evaluating supporting technical information, writing appropriate summary documentation, and supporting the response to non-conformances and questions from regulators
  • Participate in the development, review, and substantiation of product labeling and claims for products that include requirements from EPA CAA, CPSC, Right to Know Laws, etc.

Requirements

  • S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related
  • 2 years of experience in medical device regulatory affairs or quality assurance
  • Understanding of the current Regulatory environment and demonstrating the ability to perform within
  • Ability to evaluate information to determine compliance with standards, laws, and regulations

Benefits

For employees scheduled to work at least 30 hours per week, this includes health and well-being, financial fitness, career development, paid time off and more.

Employees scheduled to work less than 30 hours per week can participate in the 401(k) plan, access the Employee Assistance Program (EAP), Employee Resource Groups (ERG) and Medline Service Corps.

Every day, we're focused on building a more diverse and inclusive company, one that recognizes, values and respects the differences we all bring to the workplace.



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