Global Regulatory Strategist – Medical Devices

RiseMe; Illinois; Hybrid; USD 79,000 - 119,000; Full time

Benefits offered by this job

Health insurance

Life and disability insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP seeks a Regulatory Specialist to lead global regulatory activities for medical devices. Under supervision, you will plan strategies for new devices, launch markets, and post-market changes, ensuring compliance and quality of supporting information.

Collaborate with cross-functional teams to prepare submissions, review documentation, and support regulatory responses. Travel up to 5% to coordinate with global/regulatory partners.

Qualifications

• Two years of experience in medical device regulatory affairs or quality assurance.
• Knowledge of current regulatory environment and FDA regulations/guidelines.
• Ability to evaluate information to determine regulatory compliance.

Responsibilities

• Determine requirements for completing and maintaining product submissions and regulatory filings for clearance/approval in assigned markets.
• Communicate regulatory requirements to internal or external customers and recommend pathways.
• Review and provide feedback on documentation to ensure regulatory requirements are met.
• Complete/regulatory filings by coordinating with internal/external groups and addressing questions from regulators.
• Contribute to development and substantiation of product labeling and claims.
• Present objectives with team members and provide regulatory expertise.

Skills

FDA regulations

Regulatory strategy

Regulatory affairs

Education

Bachelor’s degree in life sciences

Job description

Medline Industries, LP seeks a Regulatory Specialist to lead global regulatory activities for medical devices. Under supervision, you will plan strategies for new devices, launch markets, and post-market changes, ensuring compliance and quality of supporting information.

Collaborate with cross-functional teams to prepare submissions, review documentation, and support regulatory responses. Travel up to 5% to coordinate with global/regulatory partners.