Job Description
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.