Participate in multi-functional project teams, prepare and advise on regulatory strategy, file regulatory submissions with FDA and worldwide agencies. Assist with system compliance with US and worldwide regulations.
• Prepares and manages regulatory submissions to FDA, Notified Bodies and other agencies.
• Negotiates and communicates effectively with regulatory authorities to obtain timely product approvals.
• Researches regulatory pathways and pursues 510K, DeNovo, PMA and equivalent international routes in tune with overall strategy of company.
• Understands technical details of devices and helps in risk management activities.
• Advises teams on effective methods to comply with regulatory and quality requirements.
• Assists in conduct of internal and supplier audits.
• Bachelor’s degree in Engineering or Science discipline. Master’s degree preferred.
• At least 7 years experience in regulatory affairs in the medical device industry.
• Sound knowledge of ISO 13485, 21 CFR 820, CMDR, and other international regulations.
• Exceptional verbal and written communication skills targeting both internal and external audiences
• Effective interpersonal skills exemplified by an articulate, persuasive and enthusiastic manner.
• Strong listening skills with an emphasis on finding the best ideas.
• Capability to multi-task in a small company environment
Vapotherm - 12 months ago