Regulatory Affairs Senior Specialist, New Product Development at Jobgether – United States

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Regulatory Affairs Senior Specialist, New Product Development in the United States.

This role offers an opportunity to lead regulatory strategy and submissions for new product development projects, including diagnostic assays, instruments, and software systems. You will serve as the regulatory affairs expert on cross-functional teams, ensuring products meet regulatory requirements and launch timelines are achieved. The position involves preparing submissions, monitoring regulatory reviews, and advising on the impact of business and product decisions. You will collaborate with project teams, contribute to regulatory planning, and provide training to stakeholders. Exposure to diverse projects and the chance to influence product availability make this a highly impactful and growth-oriented role. This position is well-suited for professionals who thrive in dynamic environments and seek to advance their career in regulatory affairs.

• Lead regulatory activities for new product development projects, providing expertise on diagnostic assays, instruments, software, and system projects.
• Prepare, review, and submit regulatory documents including 510(k), PMA, and pre-submissions, ensuring compliance with applicable guidelines and timelines.
• Partner with cross-functional teams to advise on regulatory impact of product or business decisions and to ensure on-time delivery of product launches.
• Monitor and manage regulatory submissions under review, responding promptly and negotiating with authorities as needed.
• Contribute to the development and maintenance of project master schedules and regulatory deliverables.
• Provide regulatory training and guidance to internal stakeholders to promote compliance and understanding of regulatory requirements.
• Track and implement changes in regulations and guidance that may affect product development and submissions.

Requirements:

• Bachelor’s degree with 5+ years of related experience, Master’s degree with 3+ years, or Doctoral degree with 0–2 years of experience in Regulatory Affairs or related field.
• In-depth knowledge of regulatory affairs principles and familiarity with regulations governing diagnostic product development.
• Experience supporting FDA 510(k) submissions, including authoring, compiling, and reviewing regulatory documentation; PMA experience preferred.
• Strong organizational, analytical, and prioritization skills with the ability to manage multiple projects simultaneously.
• Ability to succeed in a fast-paced, dynamic environment with flexibility and adaptability.
• Effective communication and collaboration skills to work across teams and guide stakeholders on regulatory matters.
• Previous experience serving as a core team lead on projects or evaluating study protocols and reports is a plus.

Benefits:

• Competitive salary within the $92,500 – $127,500 range, plus eligibility for bonus/incentive pay.
• Comprehensive health, dental, and vision insurance.
• Paid time off and flexible, remote work options.
• Retirement savings plan (401k) and additional benefits to support life beyond work.
• Professional growth opportunities within regulatory affairs and exposure to diverse product development projects.
• Supportive work environment promoting career development, well-being, and continuous improvement.