Staff Regulatory Affairs Specialist, Mako and Enabling Technologies

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

📋 Description

• Formulate and implement global regulatory strategies for new products, modifications, and lifecycle management initiatives.

• Engage in product development teams to integrate U.S., European, and international regulatory standards throughout the development stages.

• Assess product classifications, regulatory pathways, and jurisdictional requirements for medical devices and associated technologies.

• Draft and submit regulatory documents, including FDA submissions, international registrations, and necessary support documentation for product approvals.

• Examine quality, preclinical, and clinical documentation for readiness of submission and adherence to regulatory standards.

• Collaborate with global regulatory affiliates on registrations, market expansions, and post-market regulatory obligations.

• Oversee interactions with regulatory authorities and notified bodies, including responses, submissions, and communications with agencies.

• Evaluate product labeling, marketing materials, and product claims for regulatory compliance.

• Guide junior regulatory team members on regulatory processes and best practices.

⛳️ Requirements

• Bachelor’s degree in Engineering, Sciences, Regulatory Affairs, or a related discipline.

• At least 4 years of experience within an FDA-regulated environment.

• Minimum of 3 years of experience in Regulatory Affairs.

• Experience in preparing regulatory submissions for product approvals.

• Preferred: Regulatory Affairs Certification (RAC) and/or a Master’s degree in Regulatory Affairs or a related field.

• Preferred: Experience supporting Class II and/or Class III medical devices.

• Preferred: Experience in authoring FDA 510(k) submissions.

• Preferred: Experience with direct interactions with regulatory agencies and notified bodies.

🏝️ Benefits

• Remote position.

• Preference for candidates based in the U.S. Eastern Time Zone.

• Travel Percentage: None.