Global Regulatory Lead - Submissions (Remote)

Medline Industries, LP; United States; Remote; USD 116,000 - 174,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a Principal Regulatory Affairs professional to develop regulatory strategies for global product approvals and maintain existing products. The role is remote and requires leadership in negotiations with regulatory authorities, guiding major projects, and informing future product development.

Ideal candidates have 5+ years of diverse regulatory experience in medical devices, including 510(k) submissions and CE Technical Files, with strong cross-functional

Qualifications

• 5+ years of diverse global regulatory experience in the medical device industry.
• Extensive experience authoring and submitting regulatory submissions including 510(k)s and CE Technical Files.
• Ability to lead cross-functional groups and interact with regulators.

Responsibilities

• Determine requirements for product submissions and regulatory filings for clearance/approval in assigned markets.
• Communicate regulatory requirements to internal/external stakeholders and propose regulatory pathways.
• Review evidence to ensure compliance with regulations, guidance, and standards.
• Lead internal groups to maintain regulatory filings and coordinate with regulators on inquiries/non-conformances.
• Oversee development, review, and substantiation of product labeling and claims for different markets.
• Manage complex projects with timelines and cross-functional teams; identify and fix process gaps.

Skills

Regulatory experience

Regulatory submissions

Regulatory strategy

Education

Bachelor's degree in life sciences

Job description

Medline Industries, LP is seeking a Principal Regulatory Affairs professional to develop regulatory strategies for global product approvals and maintain existing products. The role is remote and requires leadership in negotiations with regulatory authorities, guiding major projects, and informing future product development.

Ideal candidates have 5+ years of diverse regulatory experience in medical devices, including 510(k) submissions and CE Technical Files, with strong cross-functional