Sr. Regulatory Affairs Specialist

Employer Industry: Digital Health and Medical Devices

• Opportunity for career advancement and growth within the organization
• Work remotely with a flexible schedule
• Involvement in innovative digital products and AI technologies
• Competitive salary and benefits package
• Work in a dynamic and collaborative environment with cross‑functional teams
• Chance to make a significant impact on regulatory compliance and product development

• Represent Regulatory Affairs on cross‑functional project teams, providing strategic input and technical guidance on product lifecycle planning
• Assess documentation for medical device submissions and communicate regulatory guidance effectively
• Assist in the development and review of Standard Operating Procedures (SOPs) for new product offerings
• Maintain technical documentation necessary for obtaining and maintaining regulatory approvals
• Work with clinical teams to ensure compliance for pre‑ and post‑market clinical studies

• Bachelor's degree in a relevant field or equivalent experience
• 8‑12 years of experience in a regulated industry, preferably with FDA and Software as a Medical Device
• Strong knowledge of FDA Quality System Regulations, including 21 CFR 11 and 21 CFR 820
• Experience drafting and submitting regulatory filings for Software as Medical Device
• Excellent written and oral communication skills

• Experience with US FDA Class I and II medical devices, and familiarity with Class III devices
• Knowledge of Medical Devices Regulations (MDR 2017/745, ISO 13485, etc.)
• Experience interacting with US and OUS Regulatory Authorities, including Q‑Submission meetings
• Understanding of pre‑ and post‑market clinical studies and relevant regulations

#Digital Health #Regulatory Affairs #Medical Devices #Remote Work #Career Growth

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