Senior Regulatory Specialist - Remote

Overview

The Senior Regulatory Specialist is responsible for supporting DeepHealth’s product and product development and regulatory activities to commercialize new digital products, including AI technologies.

In Short

• Represent Regulatory Affairs on cross functional project teams.
• Assess documentation for medical device submissions.
• Assist in SOP development for new product offerings.
• Revisit regulatory outcomes for future recommendations.
• Create and maintain technical documentation for regulatory approval.
• Assist in preparation of regulatory submissions.
• Evaluate design changes for regulatory impact.
• Ensure compliance with post marketing requirements.
• Review product labeling for compliance.
• Work with clinical teams for study compliance.

Requirements

• Bachelor’s degree in relevant field or equivalent experience.
• Strong knowledge of FDA Quality System Regulations.
• 6-8 years in a regulated industry (FDA and Software as a Medical Device preferred).
• Experience drafting and submitting regulatory filings.
• Experience with US FDA Class I and II medical devices.
• Experience interacting with Regulatory Authorities.
• Knowledge of pre- and post-market clinical studies.
• Understanding of Medical Devices Regulations.
• Excellent written and oral communication skills.

Benefits

• Join a dynamic team with expertise in various fields.
• Collaborative and agile work environment.
• Continuous learning opportunities.
• Fully remote working environment with flexible hours.
• A salary in line with job level and experience.