Medical Device Auditor/ Compliance Specialist (offline)

ABOUT AUDITDATA

Danish company, Auditdata A/S (www.auditdata.com), for more than 25 years now has been successfully uniting disruptors, creators and challengers who are passionate about driving transformational change in our industry aimed at empowering audiology care providers to help more hearing-impaired people reconnect to the world and run a better business. In short, we want to make great clinical care a great business.


As Medical Device Auditor, you will perform ISO/IEC 27001:2013 Audit and Certification procedures and the requirements for ISO 27001, ISO 13485, and EC Certificates. Our future Auditor will be responsible to make relevant decisions concerning the audit process including collecting and analyzing sufficient information for providing a recommendation for certification.

RESPONSIBILITIES:

 Perform audits for Auditdata medical devices quality systems and information to the requirements of ISO 27001, ISO 13485, EC Certificates and other regulatory requirements.
 Participate in professional development and training opportunities to achieve necessary certifications and statuses
 Provide basic training and instructions to new customers/partners

OUR SUCCESSFUL CANDIDATE IS/HAS:

 Fluent English proficiency (written and spoken)
 2+ years’ experience in a similar role and industry
 Strong customer orientation, willingness to assist and solve customer issues
 Result oriented and “can do” attitude
 Strong coordination and communication skills
 Able to work independently and as part of a team

Will be a plus:

 Knowledge about Audiometry (hearing aid fitting process) as well as clinical management process








AUDITDATA OFFERS:

 Long-term, secure engagement in the stable PRODUCT company
 Scandinavian management style and culture
 Great company values and ethics
 Full cycle SW/HW product development according to high business standards
 Professional development (incl. related certifications)
 Educational opportunities (paid trainings & courses)
 Friendly family-like, "hygge" atmosphere:) with regular social activities & team-buildings
 Competitive salary package
 Comprehensive health insurance
 Annual paid vacation to support healthy work/life balance
 Modern office facilities in central Kyiv
 Possibility of remote work

We would love to welcome you on board!

About Edvantis

Do you care about developing products that can change people’s life for better?
Are you passionate about Microsoft Technology stack?
Do you know what “hygge” means?:)

If your answer is “yes” to all of the above, then Auditdata is looking for you — talented, proactive and compassionate individual to join our international team in Kyiv office.

Danish company, Auditdata A/S, for more than 25 years now has been successfully providing state of the art technology solutions within Audiology healthcare domain worldwide. Our software and hardware products help people breaking their hearing loss physiological and psychological barriers to significantly improve their life quality.

We are pioneers and #1 choice for hearing care professionals because we care!

Company website:
http://www.auditdata.com

DOU company page:
https://jobs.dou.ua/companies/auditdata/