Director of Regulatory Affairs - Remote

Overview

The Director, Regulatory Affairs is a highly respected, technically accomplished individual contributor and team leader responsible for providing regulatory expertise and mentoring junior team members while contributing to the strategic vision of the RQM+ Regulatory Affairs team.

In Short

• Serve as a regulatory affairs expert with billable contributions.
• Meet personal utilization targets while mentoring colleagues.
• Provide expert guidance on global regulatory strategies.
• Support operationalization of long-term vision for emerging regulatory needs.
• Assist in building frameworks for process improvement.
• Lead initiatives to identify knowledge gaps and propose training.
• Contribute to marketing campaigns and represent RQM+ externally.
• Serve as a strategic partner to Business Development teams.
• Provide mentorship and development support to direct reports.
• Contribute to continuous process improvements.

Requirements

• Bachelor’s degree in a scientific or engineering discipline; advanced degree preferred.
• 15 years of experience in the medical device industry, with 10 in regulatory roles.
• Strong knowledge of US FDA and/or EU regulatory frameworks.
• Demonstrated expertise in regulatory strategy development.
• Proven ability to operate as both an individual contributor and team leader.
• Experience mentoring team members.
• Strong business acumen and operational efficiency drive.
• Prior consulting experience preferred.
• Effective communicator and relationship builder.
• Ability to navigate ambiguity while focusing on execution.

Benefits

• Work in a collaborative and innovative environment.
• Opportunity to mentor and develop junior staff.
• Engagement in strategic initiatives within the company.
• Flexible work schedule to accommodate client needs.
• Supportive company culture aligned with client-first excellence.