Regulatory Specialist - Remote

Overview

The Regulatory Specialist is responsible for supporting product development, ensuring compliance with the relevant regulatory requirements and interactions with regulatory authorities. The successful applicant will collaborate closely with all teams within the organization to fulfill DeepHealth’s mission.

In Short

• Plan, define and coordinate processes related to product Regulatory approval.
• Collaborate with engineering and product teams to ensure regulatory compliance.
• Provide regulatory guidance for product registration.
• Create and maintain technical documentation for regulatory approvals.
• Execute and document clinical risk assessment sessions.
• Ensure compliance for pre- and post-market clinical studies.
• Enforce compliance to applicable standards.

Requirements

• Bachelor’s degree in relevant field or equivalent experience.
• Knowledge of Medical Devices Regulations, ISO standards.
• 2 - 4 years in a regulated industry (FDA and Software as a Medical Device preferred).
• Experience drafting and submitting regulatory filings.
• Experience interacting with Regulatory Authorities.
• Knowledge of pre- and post-market clinical studies.
• Excellent written and oral communication skills.

Benefits

• Ability to work remotely.