Senior Regulatory Affairs Specialist

Do regulatory affairs make you excited, and would you like to go to work knowing that you contribute to getting innovative treatments and devices to people who need them faster? Join us in a challenging position as Senior Regulatory Affairs Specialist in a med-tech company that strives to revolutionize the market for clinical biomarker and virus tests.

About QLIFE

Qlife focuses on enabling tests at home. As a complement to tests in healthcare, access to important health information is facilitated, which can contribute to better treatment and potentially prevent diseases. Our product The Egoo, a small fist sized and portable device, analyzed testing is provided. The tests can be made from mouth swab, and takes 5-30 minutes for most tests. Results are qualitative on par with existing laboratory tests. The tests are run from a laptop and the results are shown instantaneously. 

About The Team

Qlife is growing and looking for a new colleague to join our dedicated team. At Qlife we are working in an innovative and creative environment where we, together, want to make an impact towards our long term goal of giving people access to safe and validated biomarker data at home. You will become a part of a workplace, where your work helps make a difference for the people who use our product. As a team we focus on creating a motivating environment within and across projects - and last but not least having fun along the way.

The Process

Does this job offer interest you then apply with the form on this site as soon as possible with a resume and a cover letter. We are conducting interviews on an ongoing basis and we will not hesitate to hire the right candidate on the spot.

 

Should you have any questions regarding the position, the company or anything in between, please do not hesitate to contact Kristina Christensen - KC@egoo.health - +45 2031 1520.

THE JOB

As our Senior Regulatory Affairs Specialist, you will be responsible for evaluating product classification and regulatory pathways, and for developing and maintaining Regulatory Strategy/Plan.

 

Your tasks as our Senior Regulatory Affairs Specialist would be to:

  • Provide regulatory input on applicable county-specific requirements for product development and throughout the product life cycle.

  • Assist in developing regulatory procedures and SOPs and participate in implementation.

  • Assist in training of stakeholders on current and new regulatory requirements to ensure compliance.

  • Support submission activities for a variety of device regulatory approvals including CE mark, US premarket approvals (PMAs), US Premarket Notifications 510(k), post-approval reports, export certificates, establishment registrations, and device listings.

  • Evaluate product documentation for submissions.

  • Monitor progress of regulatory review process and communicate with agency.

  • Prepare technical files, regulatory dossiers in support of registrations worldwide.

  • Develop and implement processes involved for maintaining annual licenses, registrations, and listings.

  • Evaluate product changes and evaluates impact to products on market and in development.

  • Review labeling and promotional material.

  • Provide regulatory input and follow-up for inspections and audits.

YOUR COMPETENCES

To succeed in this job, you'll combine your knowledge of scientific, legal and business issues to ensure products, which are developed, manufactured or distributed by Qlife. We imagine that you hold a bachelor’s Degree. Ideally, you have a minimum 4 years of experience working in the diagnostic industry, in vitro diagnostics preferred, and a minimum of 2 years of regulatory Affairs experience.

Experience in writing and preparing Regulatory Documents is required.  

YOUR PROFILE

As a person you are self-motivated and have a strategic mindset. You bring an innovative, structured and analytical perspective, and are detail oriented and capable of digesting large amounts of complex data

We imagine that you: 

  • Have a strong collaborative approach towards stakeholders.

  • See yourself as a good listener with strong communicative skills.

  • Speak and write fluent English.

What we offer the right candidate

If you are our next Senior Regulatory Affairs Specialist, you are directly helping to pave the way for the Egoo Health System. 

The job is located at our facility in Ballerup, it is a full time position.


You will be working in an innovative and creative environment where we together want to make an impact towards our long term goal of giving people access to safe and validated biomarker data at home. You will become a part of a workplace where your work can help make a difference for the people who use our product.

 

As a colleague you will experience that we have a focus on creating a motivating environment within and across projects and teams - and last but not least having fun along the way. 

Let's Work Together

Apply here!