Senior Regulatory Lead - Medical Devices & FDA Submissions

Treace; Ponte Vedra Beach (FL); On-site; USD 110,000 - 140,000; Full time

Job summary

Treace is seeking a Senior Regulatory Affairs Specialist II to lead regulatory submissions and guidance across product development, quality, and marketing. You will coordinate US FDA 510(k)/Q-submissions and international filings, collaborating with multiple teams to ensure timely clearance and compliant labeling.

The role requires 7+ years in Regulatory Affairs within medical devices (US FDA Class II) and a RAC is preferred.

Qualifications

• Bachelor’s degree in Engineering, Science, or relevant technical discipline is required.
• Minimum of 7 years of Regulatory Affairs related experience in a medically regulated environment with at least 5 years in a medical device company (US FDA Class II) is required.
• Regulatory Affairs Certification US (RAC) through Regulatory Affairs Professional Society (RAPS) is preferred.

Responsibilities

• Serves as the Regulatory representative providing regulatory guidance to product development and sustaining project teams.
• Authors US FDA premarket submissions (e.g., 510(k), Q-submissions) and international submissions with collaboration from key staff in Product Development, Operations, Marketing, and Quality for timely submissions.
• Serves as primary contact for regulatory agencies on assigned submissions and negotiates submission data requirements and deliverables with regulatory authorities and product development teams for timely clearance.
• Authors regulatory assessments for proposed changes to products or processes.
• Collaborates with Marketing, Sales, Legal and Regulatory partners for timely review of advertising and promotional materials as well as product labeling.
• Monitors regulatory landscape changes and authors impact assessments to key proposed or issued regulatory guidance, directives, and legislation. Interprets changes for implementation into TMC processes.
• Maintains US FDA and international registrations and device listings.
• Supports the Unique Device Identifier (UDI) requirements including US FDA Global Unique Device Identification Database (GUDID) and international UDI submissions.
• Maintains regulatory data, files, and daily regulatory operations.
• Participates in audits by regulatory authorities, certification bodies, or internal auditors.
• Mentors junior Regulatory staff and guides for cross-functional understanding of applicable regulatory requirements and processes.
• Develops and implements new Regulatory processes and procedures and conducts Regulatory trainings for departmental and cross-functional understanding of regulatory requirements and procedures.

Skills

Regulatory submissions

Regulatory strategy

Cross-functional collaboration

Documentation & data management

Audits & compliance

Education

Bachelor’s degree in Engineering, Science, or relevant technical discipline

Regulatory Affairs Certification (RAC)

Tools

GUDID knowledge

Job description

Treace is seeking a Senior Regulatory Affairs Specialist II to lead regulatory submissions and guidance across product development, quality, and marketing. You will coordinate US FDA 510(k)/Q-submissions and international filings, collaborating with multiple teams to ensure timely clearance and compliant labeling.

The role requires 7+ years in Regulatory Affairs within medical devices (US FDA Class II) and a RAC is preferred.