Principal Regulatory Affairs

Medline Industries, LP•REMOTE- Illinois, IL

5d•$116,000 - $174,000•Remote

About The Position

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.

Requirements

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, including support of pre- and post-market regulatory activities, independent submissions, participating in regulatory intelligence programs, and development and implementation of regulatory strategies in multiple international markets.
Sound background and ability to lead efforts related to technical fields such as risk management and design and development.
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.

Responsibilities

In support of business priorities, determine the requirements for completing and maintaining product submissions and regulatory filings for clearance/approval in assigned market(s), including for national or multi-national launch projects.
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; actively propose and execute necessary changes to impacted procedures, products, or records.
Acquire and apply knowledge of harmonized standards where applicable.
Communicate requirements of regulations to internal or external customers.
Recommend regulatory pathways, strategies, solutions, and future actions for specific and diverse scenarios, accounting for business objectives and factors relevant to other departments/functional areas.
Review and provide direction to ensure supporting evidence meets appropriate regulatory requirements.
Assess records against multiple requirements sources, including regulations, guidance documents, and standards utilized in various applicable markets that have been identified as applicable.
Direct and take action to complete and maintain regulatory filings by leading internal groups, collaborating with external groups, providing direction to obtain supporting technical information, and implementing focused solutions for identified changes and challenges.
Lead direct communication with critical regulators to respond to non-conformances and questions.
Lead processes and projects involving the development, review, and substantiation of product labeling and claims where needed for various markets and projects.
Manage complex projects by providing direction on diverse regulatory pathways, defining timelines for technical deliverables and multifaceted project teams, identifying and correcting process deficiencies, and defining future actions and solutions.
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.