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Regulatory Manager / Internal Auditor (ISO 27001, 13485)

ABOUT COMPANY
Danish company, 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.

ABOUT PROJECT

As an Internal Auditor, you will be responsible that our company is compliant with both ISO 27001 and ISO 13485 and for continuous recertification of our products, services and company sites. Our future Auditor will be responsible to make relevant decisions and recommendations concerning the audit and certification processes including collecting and analyzing sufficient information and coordinating with relevant parties.

Office Location

Kyiv, 23A Sichovykh Striltsiv (Artema)

Conditions

Conditions: Competitive salary package, comprehensive health insurance, an annual paid vacation of 24 business days to support a healthy work/life balance. Remote work or mix with the office.

Responsibilities

  • Organize and maintain our quality and information security management system, so the company can accomplish external audits and get country-specific medical standard approvals (e.g. CE mark, FDA, MDSAP, NHS etc)
  • Monitor premarket and post-market regulatory requirements and implement the necessary updates and changes internally in the organization and in our quality management system
  • Collaborate with relevant people in the organization to ensure all documentation and regulatory processes are kept according to the agreed timeline and requirements
  • Perform internal audits for Auditdata quality and information security management system (QIMS) in accordance with ISO 27001, ISO 13485, certificates, and other regulatory requirements.
  • Organize and support external audits for recertification and physical site audits, handle communication with external auditors, manage agenda, submit the necessary documentation and follow up on CAPA
  • Research and apply all required regulatory documentation when Auditdata is entering new markets with their products
  • Participate in professional development and training opportunities to achieve necessary certifications and statuses
  • Provide basic training and instructions to the new customers, partners, employees

Requirements

  • Fluent English proficiency (written and spoken)
  • Strong coordination, communication skills, ability to collaborate with internal & external stakeholders
  • 4+ years’ experience in a similar role and industry
  • Strong knowledge of the required ISO standards
  • Strong customer orientation, willingness to assist and solve customer issues
  • Result oriented and “can do” attitude
  • Self-driven and motivated individual
  • Project management skills
  • Rational approach and unbiased evaluation/mindset

Preferred/Nice to have skills

  • Experience with Aras document management system
  • Knowledge about Audiometry (hearing aid fitting process) as well as a clinical management process

Why is this professional opportunity an excellent career step for you?

  • Long-term, secure engagement in the stable PRODUCT company within the healthcare industry
  • 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!

Don’t miss your chance & send your resume