Senior Regulatory Affairs Program Lead – Robotics & Digital Solutions, MedTech Surgery

Jobtailor; California (MO); On-site; USD 120,000 - 180,000; Full time

Job summary

Jobtailor is seeking an experienced Regulatory Affairs professional in the United States to drive regulatory strategy for new medical device products. You will collaborate across engineering, quality, and marketing to prepare and file FDA submissions and ensure global health authority compliance.

The role requires 6+ years in regulatory affairs for medical devices, with strong documentation, communication, and project management skills. Advanced degrees are a plus; remote work options may vary.

Qualifications

• Bachelor's degree required; Advanced degree highly desired (Science, Engineering, or related field).
• 6+ years of regulatory affairs experience in medical devices (4+ years with advanced degree).
• Experience with medical device regulatory submissions (FDA and global authorities).
• Track record developing and implementing regulatory strategies.

Responsibilities

• Instill and drive a vibrant regulatory culture across cross functional groups.
• Develop and implement regulatory strategies for new product clearances and approvals.
• Prepare and submit FDA submissions (e.g., Q-submissions, IDEs, De Novo, 510(k)) and global health authority documents.
• Serve as Regulatory Affairs SME on new product development and design control teams.
• Provide regulatory feedback on specifications, device testing, risk management, and submissions.
• Identify issues, communicate timelines, and address complex registration-related challenges.
• Evaluate regulatory changes and assess business impact for submissions.
• Guide conformance with regulations in product development, labeling, and promotions.
• Assist in developing Regulatory Affairs processes.

Skills

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

Project prioritization

Attention to detail

Communication skills

Presentation skills

Global health authority interactions

Medical device software guidance

Education

Bachelor's degree

Advanced degree (Science/Engineering)

Job description

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 authority submissions technical documents.
• Serves as a Regulatory Affairs subject matter expert on new product development and engineering design control teams.
• Conducts reviews and provides expert regulatory feedback for specifications, device testing, risk management, and other relevant documentation in accordance with regulatory requirements and with 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 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 is required (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.
• 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.