Senior Regulatory Affairs Program Lead – Robotics & Digital Solutions

Responsibilities

• Instills and drives a vibrant regulatory culture, working among cross‑functional groups as a teammate and collaborator.
• Applies strategic regulatory thinking along with technical expertise to develop and implement regulatory strategies for new product clearances and approvals.
• Prepares and submits regulatory information required to obtain global market access, including preparation, writing and filing of FDA submissions (e.g., Q‑submissions, IDEs, De Novo, 510(k)s) and global health authorities’ technical documents.
• Serves as a Regulatory Affairs subject‑matter expert on new product development and engineering design‑control teams, conducting reviews and providing expert regulatory feedback for specifications, device testing, risk management, and other relevant documentation in accordance with regulatory requirements and positioning for regulatory submission.
• Proactively identifies issues, effectively communicates timelines for project completion, and addresses complex issues that may impact registration status.
• Conducts regulatory evaluation of changes to devices in accordance with the requirements of commercial/operating geography and generates the required regulatory submission (including Letters To File).
• Guides conformance with applicable regulations and guidance documents in product development, support of claims, content labeling, and promotional materials.
• Assists in the development of Regulatory Affairs processes.

Requirements

• Minimum of a Bachelor's degree required; advanced degree highly desired (desired areas of study include science, engineering, or related field).
• Minimum of 6+ years of related Regulatory Affairs experience within Medical Device (4+ years with advanced degree).
• Experience with medical device regulatory new product submissions required.
• A demonstrated track record of developing and driving implementation of regulatory strategies.
• Working knowledge of how global regulations impact product registration.
• Good communication skills for effective collaboration with cross‑functional partners.
• Corresponding and collaborating with colleagues globally for strategic contribution and achievement of regulatory milestones.
• Evaluating new regulatory requirements as well as regulatory changes and correctly assessing business impact.
• Excellent verbal and written communication skills; strong attention to detail.
• Advanced analytical and problem‑solving skills.
• High organization skills with the ability to lead multiple projects/tasks simultaneously and effectively prioritize projects and tasks.
• Strong learning skills for complex technology and presentation skills to allow presentation of complex regulatory strategies in a clear, concise, and comprehensive fashion.
• This position will require up to 25% travel.
• Previous experience with health authority meetings/interactions.
• Experience with medical device software guidance, IEC 60601, sterilization, biocompatibility, and reprocessing requirements and their documentation in submissions.

Core Competencies

Demonstrates expertise in Regulatory Affairs with a focus on medical device submissions, including FDA and global health authority requirements. Capable of developing and implementing regulatory strategies while effectively collaborating with cross‑functional teams.