[Hiring] Principal Regulatory Affairs @Medline Industries, LP

Role Description

Medline Industries has an immediate opening for a Principal Regulatory Affairs. This role will be remote. Responsible for developing regulatory strategies for global approvals that introduce new products to market and maintain existing products. The position is responsible for negotiating with regulatory authorities, and inform future product development. This position must function independently to resolve regulatory issues, provide direction on projects of large scale with significant business impact, negotiate with regulatory authorities, and inform ongoing project and product development. The Regulatory Specialist Principal leads work groups as a recognized expert in various and diverse area(s) of regulatory and technical competency.

• Determine the requirements for completing and maintaining product submissions and regulatory filings for clearance/approval in assigned market(s).
• Identify and provide solutions for factors that could impact the success or viability of new product launch in assigned market(s).
• Monitor changes in regulations that impact current or future requirements and overall compliance.
• Communicate requirements of regulations to internal or external customers.
• Recommend regulatory pathways, strategies, solutions, and future actions for specific and diverse scenarios.
• Review and provide direction to ensure supporting evidence meets appropriate regulatory requirements.
• Direct and take action to complete and maintain regulatory filings by leading internal groups and collaborating with external groups.
• Lead processes and projects involving the development, review, and substantiation of product labeling and claims.
• Manage complex projects by providing direction on diverse regulatory pathways.
• Proactively review, improve, and develop regulatory-driven and technical processes.
• Propose, establish, and maintain department databases, logs, and files necessary for ensuring ongoing compliance.
• Oversee and lead internal and external audits and manage post-audit corrective actions.

Qualifications

• B.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related.
• Strong global background (5+ years) of diverse regulatory experience in the medical device industry.
• Extensive experience authoring and submitting regulatory submissions including 510(k)s and CE Technical Files.
• Extensive experience communicating and negotiating with regulatory agencies, including FDA and notified bodies.

Requirements

• None

Benefits

• Competitive total rewards package.
• Continuing education & training.
• Tremendous potential with a growing worldwide organization.
• Health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average.
• For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, and access to the Employee Assistance Program.