Quality Assurance and Regulatory Affairs Manager (QA/RA Manager)

Here is a unique opportunity to become a key member of RemissHjälpen as our Quality Assurance and Regulatory Affairs Manager (QA/RA Manager).  We are an early stage health-tech start-up obsessed with creating frictionless care chains, strongly value based and, on a mission to improve health care for millions around the world. We expect a rapid growth during the coming years and would love nothing else than to have you onboard with us!

We are on the look-out for a person who would LOVE to join us on this journey for the long haul. Firmly believing that this is the time to digitize and improve the healthcare industry.

About the job

As our QA/RA Manager you will have a really broad scoop of responsibilities, all of them related to the regulatory compliance. You establish and implement product registration strategies and plans for new markets and you lead the work of getting product documentation in compliance with MDR. We are already in process for being MDR-compliant and you will be in charge of leading the work forward. Being part of a small company also calls for an operational (and truly flexible) mindset. Deviation management, complaints, CAPA, internal/external audits and risk management are parts of your daily work. You also handle registration, updates and re-registration of our products.

In this position you also keep contact with relevant competent authorities and Notified body, you contribute to the post market surveillance and of course you support colleagues with quality and regulatory questions as kind of the go-to-person or subject matter expert. The company is currently building its own multidimensional SaaS patient/healthcare platform that will enable faster, more correct and digital ways to handle communication between healthcare professionals and between patients and healthcare professionals. You will be part of the management team and work closely together with our CEO, CTO, CFO and business developer.

We believe you have

·       Experience in quality assurance and regulatory affairs working with software medical devices controlled by MDD/MDR.

·       A university degree in Life Science, Technology or equivalent.

·       A good understanding of applicable medical device regulations and standards.

·       Some knowledge of labelling requirement within the medical device industry.

·       Experience from additional quality system/ISO standards is valued.

·       The language knowledge making you fluent in Swedish and English, verbally and in written text.

We hope you are the one

We are always looking for unique talents and are hoping you are that unique talent. If you, like us:

-       Have a passion for doing good

-       Appreciate the high pace in a small and dynamic company

And:

-       Have a really good knowledge of both quality and regulatory requirements

-       Is well organized and have a structured way of working

-       Have an ability and willingness to handle many different tasks and changes of priorities

-       Feel comfortable although you cannot always do much better than ”good-enough”. 

Then… We hope to be the match for you!

Location and colleagues

The job is primarily located in Jönköping although we are open to the possibility of you working with us at our office in Stockholm as well. The company has two offices. One located in Stockholm, and one in Jönköping. The office in Jönköping is new and will open 15/2. There you will be accompanied by two new colleagues and have the opportunity to make your own mark. Currently the company has around 20 employees and consultants working from Stockholm, Gothenburg, Jönköping and abroad.

Apply today!

We look forward to your application!