QA/RA Manager (FDA/MDR) (offline)

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?

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 hands-on experience with securing regulatory approvals, including developing processes and authoring of associated documentation such as standard operating procedures. You have a relevant higher education, but your hands-on experience is of the utmost importance.

Your experience includes:

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.
An 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.
An operational ‘doer.’
An entrepreneurial profile who loves working on the entire process, right 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

About Audientes

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 Q3 2021 before being introduced to the US OTC market and other markets. Audientes’ mission is to help the many millions who suffer from disabling hearing loss but cannot afford to buy one of the expensive conventional hearing aids on the market.

Today, nearly 500 million people globally suffer from disabling hearing loss, of whom 400 million do not have a quality solution to address their hearing loss. This is indeed a global health issue. Audientes wants to be part of the solution to this issue by offering affordable, self-fitting binaural hearing aids for the benefit of all.

Audientes is headquartered in Copenhagen, Denmark, and is listed on Nasdaq First North Growth Market Denmark (AUDNTS).

Company website:
https://www.audientes.com/

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