Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs, Worldwide Regulatory Affairs
4 Year Degree
Summary of Position:
Participate in multifunctional project teams, prepare and advise on regulatory strategy, file regulatory submissions with FDA and worldwide agencies.Assist withsystem compliance withUS and worldwide regulations. Provide direction to subordinates responsible for complaint handling and regulatory agency reporting.
Prepare and manage regulatory submissions to FDA, Notified Bodies and other agencies.
Negotiate and communicate effectively with regulatory authorities to obtain timely product approvals.
Research regulatory pathways and pursue 510K, DeNovo, PMA and equivalent international routes in tune with overall strategy of company.
Comprehend technical details of devices and assist in risk management activities.
Supervise personnel responsible for regulatory activities, complaint handling and reporting to regulatory agencies.
Develop and mentor subordinates on regulatory principles.
Advice teams on effective methods to comply with regulatory and quality requirements.
Assist in conduct of internal and supplier audits.
Bachelor’s degree in Engineering or Science discipline. Master’s degree preferred.
At least ten 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
Internal Number: 99999
About Vapotherm Inc
Vapotherm develops and manufactures innovative, comfortable, noninvasive technologies for respiratory support of patients with chronic or acute breathing disorders. Over 1 million patients have been successfully treated with Vapotherm Hi-VNI Technology, and the number is growing rapidly every day. We have an unrelenting commitment to improving patient lives, significant sales growth, a dynamic and exciting work environment, and a focus on hiring and developing the very best people in the medical device industry. Now is a great time to join our growing team. Vapotherm is a privately held company located in Exeter, New Hampshire. For more information, visit www.vapotherm.com