Regulatory Affairs Management

Job Description:

Highly visible position responsible for domestic
regulatory submission preparation for NeuroPace products. Initial
responsibilities will be focused on writing and preparing high quality
IDE related submissions. Future responsibilities include writing and
preparing original PMA and related submissions. For each regulatory
submission, assuring that planning and execution are managed
effectively, efficiently, and on schedule.

Responsibilities:
Regulatory

• Writes and manages all aspects of assigned regulatory submission projects with minimal supervision and support, including assuring that submission is executed to ensure FDA compliance and timely approval.
• Reviews, makes recommendations for appropriate changes, and approves design control plans, product and manufacturing changes, and labeling.

Project Team

• Actively provides regulatory guidance throughout the product development cycle and coordinates team inputs for, and review of, submissions.
• Provides regulatory guidance and training/mentoring to cross-functional teams.

Relationship Management

• Establishes and maintains positive relationships with project team members, senior management, and regulatory agencies.

Requirements:

• Experience in successfully presenting very complex medical technology to FDA in writing. Experience with active implantable or electronic/software medical technology highly preferred.
• Strong knowledge of IDE and/or PMA regulations, and significant experience writing and project managing IDE and/or PMA related submissions.
• Outstanding project management skills and experience in managing multiple fast-paced and high-demand projects, successfully balancing details, priorities, and schedule. Must be adept at follow-up and time management.
• Outstanding verbal and written communication skills to interact successfully with Neuropace staff and senior management, and regulatory agencies.
• Strong attention to detail is critical.
• Ability and willingness to work flexible hours.
• Bachelor's degree in a scientific or technical discipline required, advanced degree preferred.

NeuroPace is an equal opportunity employer offering
a competitive compensation and benefits package including medical,
dental, vision, 401(k), and stock options.