Principal Regulatory Affairs Specialist – Software Devices

This is a fully remote position, open to applicants in Florida.

📋 Description

• Provide regulatory direction to teams involved in product development and sustaining projects.

• Prepare US FDA premarket submissions, such as 510(k) and Q-submissions, as well as international submissions for medical and software devices.

• Collaborate with Product Development, Operations, Marketing, and Quality teams to ensure timely submissions.

• Act as the primary liaison for regulatory agencies regarding assigned submissions.

• Negotiate data requirements and deliverables for submissions with regulatory authorities and product development teams.

• Draft regulatory assessments for proposed changes to products or processes.

• Review advertising, promotional materials, and product labeling in coordination with Marketing, Sales, Legal, and Regulatory partners.

• Stay updated on changes in the regulatory landscape and prepare impact assessments.

• Interpret regulatory changes for incorporation into company processes.

• Maintain US FDA and international registrations and device listings.

• Support the Unique Device Identifier (UDI) program and US FDA GUDID submissions.

• Manage regulatory data, files, and daily regulatory operations.

• Participate in audits conducted by regulatory authorities, certification bodies, or internal auditors.

• Mentor junior Regulatory staff and facilitate cross-functional comprehension of regulatory requirements and processes.

• Create Regulatory training sessions.

• Establish Regulatory processes and procedures to enhance departmental efficiency.

⛳️ Requirements

• A Bachelor’s degree in Engineering, Science, or a related technical field is mandatory.

• A minimum of nine (9) years of experience in Regulatory Affairs within a medically regulated setting is required.

• At least seven (7) years of experience in a medical device company (US FDA Class II) is necessary.

• Two (2) years of experience with software medical devices (SaMD, SiMD) is required.

• Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society (RAPS) is preferred.

🏝️ Benefits

• Full-time employment.

• Confidential handling of applicant information in accordance with EEO guidelines.

• Protections under equal employment opportunity regulations.

• A drug-free workplace.