Regulatory Affairs Specialist

Job Summary

The Regulatory Specialist is responsible for planning and executing global regulatory activities necessary to obtain and maintain global regulatory approvals. They prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes.

Key Responsibilities

• Determine the requirements for completing and maintaining product submissions and regulatory filings for clearance/approval in assigned market(s).
• Communicate regulations to internal or external customers and 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.
• Participate in the development, review, and substantiation of product labeling and claims.
• Presents project objectives with team members and act as a regulatory resource and subject matter expert.

Requirements

Bachelor'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.

Competencies

• Understanding of the current Regulatory environment and ability to perform within it.
• Awareness of FDA regulations and guidelines.
• Ability to evaluate information to determine compliance with standards, laws, and regulations.

This role requires travel up to 5% of the time.

Medline Industries offers a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

This role is bonus and/or incentive eligible.

We strive to build a more diverse and inclusive company, recognizing, valuing, and respecting the differences we all bring to the workplace.

Medline Industries is an equal opportunity employer.