Regulatory Affairs Senior Specialist, New Product Development

TL;DR

Regulatory Affairs Senior Specialist (New Product Development): Lead regulatory strategy and submissions for diagnostic assays, instruments, and software systems with an accent on FDA compliance, product launches, and cross-functional collaboration. Focus on preparing 510(k)/PMA documents, monitoring reviews, negotiating with authorities, and advising on regulatory impacts of business decisions.

Location: Remote in the United States

Salary: $92,500 – $127,500

Company

Research and development company focused on new product development projects including diagnostic assays, instruments, and software systems.

What you will do

• Lead regulatory activities for new product development projects across diagnostics, instruments, software, and systems.
• Prepare, review, and submit regulatory documents like 510(k), PMA, and pre-submissions while ensuring compliance and timelines.
• Partner with cross-functional teams to advise on regulatory impacts and support on-time product launches.
• Monitor submissions under review, respond promptly, and negotiate with regulatory authorities.
• Contribute to project schedules, regulatory planning, and deliverable maintenance.
• Provide training and guidance to stakeholders on regulatory requirements and changes.

Requirements

• Bachelor’s degree with 5+ years, Master’s with 3+ years, or Doctoral with 0–2 years in Regulatory Affairs or related field
• In-depth knowledge of regulatory principles and regulations for diagnostic products
• Experience with FDA 510(k) submissions including authoring, compiling, and reviewing; PMA preferred
• Strong organizational, analytical, and prioritization skills for managing multiple projects
• Ability to thrive in fast-paced environments with flexibility and adaptability
• Effective communication and collaboration skills across teams

Nice to have

• Experience as core team lead on projects or evaluating study protocols/reports

Culture & Benefits

• Competitive salary plus bonus/incentive pay
• Comprehensive health, dental, vision insurance
• Paid time off and flexible remote work
• 401k retirement savings plan
• Professional growth in regulatory affairs and diverse projects
• Supportive environment focused on career development and well-being