RA/QA Manager to startup company in Stockholm

We are now looking to recruit a RA/QA Manager to a startup company in Stockholm. The company is currently building an organization with a wide range of expertise and extensive experience. With an active and diverse board of directors and operative colleagues, we continue to develop a product as a new and revolutionized solution to antimicrobial resistance.

As a RA/QA Manager you will join a company with a highly skilled senior group of like-minded individuals who are driven to develop and introduce the product and the company commercially. If this sounds interesting to you - come join us!

The position is full-time and based in Solna. We welcome your application today!


About the position
As a RA/QA Manager, you will be responsible for identifying and implement the regulatory strategy and the corresponding QMS that needs to be in place in order to commercialize the product. You will work closely with CROs to implement this as soon as possible.
Your focus will be on material suppliers, med-tech industry and pharma on a more long term basis.
Efforts will be made to adjust the compound to the end users specific needs to prove its applicability, versatility and efficiency. After reaching the US market, other lowly regulated markets will be approached while the safety of our product will be proved to gain EU market approval.

Key Responsibilities include:
• Overall responsibility for the Regulatory Affairs and QA
• Plans, organizes and realizes the regulatory affairs in the Region US and EU to start with. This includes new product registrations, re-registrations and extensions of registrations in.
• Coordinates with the management of the company, on registration priorities, strategies and preparation of dossiers and the relevant studies that needs to be done.
• Coordinates price submissions to the different price databases when that is needed.
• Partner with potential regulatory and market access experts to understand the best route to market from a regulatory point of view
• Send and prepare the different documentations needed to send the application
• Handle new product introductions, calling in appropriate technical support as needed
• Liaise regularly with the R&D team to understand what is needed to meet customer and regulatory demand
• Build a QMS system in order to start the commercialization of the product
• Awareness of regulatory environments and what is needed to go to market
• Working with CEO and COO to develop market entry strategy from a regulatory point of view.



Your profile
The suitable candidate has the following qualifications:

• At least a bachelor’s degree in a scientific discipline
• Multiple years of experience in regulatory affairs and QA within medtech and/or pharma.
• Established network in the above industries
• Well versed in the various regulatory frameworks in Europe and US for the above industries
• Fluency in English plus other language(s) is highly advantageous (German and/or French)

The ideal candidate for this position is driven, well organized and has a strong ability to build effective relationships with colleagues and collaborators. Strong communication and time management skills as well as excellent problem-solving skills are required to be successful in this role. Furthermore, we believe that you have excellent attention to detail and enjoy working in a dynamic work environment.

About the organisation
The company is currently building an organization with a wide range of expertise and extensive experience. With our active and diverse board of directors and operative colleagues, we continue to develop the product towards its implementation.
The product is a revolutionizing antibiotic regimen against pathogenic bacteria capable of functioning as an antiseptic, antibacterial in food production, and as a medicinal product. With its versatility and ability to kill a wide range of multi-drug resistant bacteria, it is among the most promising antibiotic regimen under development today.
To learn more about the company, please contact us.