Provides regulatory leadership to assigned product development program teams by providing regulatory guidance throughout the product development cycle and coordinating team inputs for regulatory submissions.
Works with business and cross-functional team to ensure alignment of global regulatory strategies with business objectives and implementation of the strategic plans.
Assesses regulatory pathways for new products and product modifications; develops regulatory strategies and tactical plans for submissions to international regulatory bodies.
Prepares and submits US 510(k) submissions.
Identifies and communicates potential risks and mitigations associated with reg. strategies.
Coordinates interactions/negotiations with U.S. regulatory agencies.
Participates in internal/external trade, professional, and standards development organizations.
Reviews and approves labels, labeling, and promotional materials.
Review’s product design and change documentation, performs regulatory assessments, and implements required regulatory actions.
Reviews clinical protocols to assure collection of appropriate data for regulatory submissions and regulatory compliance.
Monitors worldwide regulatory developments (standards, guidance documents) and communicates emerging opportunities/concerns impacting BU products.
Act as Global Business to Business RA Lead supporting pharmaceutical customer regulatory activities (ie, Combination Device Submissions, Letter of Authorization Request, Product Registration Status)
Carry out the above tasks without supervision.
Ability to read, analyze, and interpret regulatory literature and documents.
Proficient in using Microsoft Word, Excel, PowerPoint, and Project.
Strong communication (written, oral) and project management skills.
Able to handle multiple competing tasks with attention to detail.
Strong critical thinking skills.
Able to work independently to achieve objectives on or before schedule.
Demonstrated global perspective, customer-centered, cross-functional collaboration, and partnership skills.
Extensive knowledge of US medical device regulations, 21 CFR 820 -Quality System Regulation, and standards, FDA guidance documents, Good Clinical Practice standards, Good Laboratory Practice regulations.