Qualifications:
 10 years related experience in a fast-paced medical device, including start-up environment.
 Bachelor’s Degree in a scientific discipline
 Ability to review technical/regulatory documents and provide applicable inputs
 Experience of hands-on 510K and/or CE submissions for US FDA CE regulations.
 Able to provide thorough, practicable, creative but compliant solutions, consistent with
organization objectives, to a wide range of regulatory challenges
 Demonstrated change management knowledge and skill
 Experience with regulatory compliance for 21CFR 820, ISO 13485:2016, EU Medical Device
Regulation (EU MDR), and other applicable Standards
 Review and advise on labeling for compliance with regulatory filings
 Familiar with products registration internationally (i.e., Canada, Latin America, Europe, Japan,
Asia, and …. per request)
 Proficiency in Words, Excel, Power Point
 Attention to detail and organization skills
 Demonstrate excellent people skills
 RAC certificate is a plus
Responsibilities:
 Provide regulatory support to customers about company products/services.
 Closely involve or host audits from customers.
 Closely involve or responsible for regulatory registration internationally.
 Participate in audits from regulatory agencies FDA.