QA/RA Manager with FDA/MDR experience and entrepreneurial passion

At Audientes A/S, our mission is to address the increasingly global health challenge of disabling hearing loss by designing and developing smart, self-fitting and affordable hearing aids. The WHO estimates that approximately 6% of the world's population has disabling hearing loss, many of whom cannot afford to purchase a hearing aid. Our goal is to help these millions of people with high-quality and affordable hearing aids. Would you like to be a part of this mission?

If the answer is yes, then read on here:

Audientes is one of the new players in the global hearing aid market. The company has developed a new self-fitting hearing aid, which will be rolled out in the Indian market in 2021 before being introduced to the new US OTC market and other intl. markets. We now need a skilled and experienced colleague with a high degree of self-motivation to join us on this journey.

About you:

It is important that you have worked with securing regulatory approvals practically, including developing the processes and authoring the associated documentation such as standard operating procedures. You have relevant higher education, but your practical experience is of the utmost importance.

You experience include:  

• Medical devices such as hearing aids w. smartphone apps
• ISO 13485, FDA Class 2 clearance and/or CE/MDR Class IIa approvals
• Experience in defining, authoring, and maintaining processes & SOPs, ideally across the organization
• Regulatory experience in securing approvals & certifications in Asia and other markets
• Interest in coaching others in the team on how to work with quality systems
• Product creation including design control, risk management and requirement management and test management
• Corrective and Preventive Actions (CAPA) / post-marketing surveillance
• Operational doer
• Entrepreneurial profile, who will love working on the entire process, from the outset
• You speak and write English at a technically high level

About us:

Audientes' head office is located in Virum, north of Copenhagen, and the company is listed on Nasdaq First North Growth Market Denmark (AUDNTS).

For more information about Audientes, visit our website: www.audientes.com

If you are interested in hearing more about the position and our company, please contact CEO Steen Thygesen (st@audientes.com) or CTO Hossein Jelveh (hj@audientes.com) or call us on +45 77 34 16 80.