Vacant job

We are experts with a passion for making a difference, dedicated to quality and Life Science. We are also humble, ambitious, and convinced that together we can contribute to our clients' success. SallyQ offers consulting solutions in QA, computerized systems, validation, project management, and sterility assurance. We are in an exciting startup phase where we are building a strong and specialized team to meet our clients' needs. Now we are taking the next step by broadening our expertise in Regulatory Affairs. As an RA specialist with us, you will have a unique opportunity to shape and influence not only in client projects but also in SallyQ's continued development.

About the role

SallyQ is currently facing a strong demand for RA expertise, especially within MedTech but also within Pharma. Therefore, we are now taking the next step and establishing Regulatory Affairs as a new area of expertise with us. We do this not only because our clients need support, but also because we at SallyQ are missing you, who can strengthen us with knowledge, perspective, and experience in this field. We believe that in the long run, you may want to help build the RA business area within SallyQ.

You will join a young company where the role involves working closely with our clients on regulatory and quality-related challenges, both at a strategic and operational level. The assignments vary in scope and complexity, providing great opportunities for development while your experience creates clear value. At the same time, you will become an important part of a young and warm company where everyone contributes to building the culture, structures, and community. Where everyone is involved in contributing to our shared success. The work mainly takes place at the client's site, complemented by remote work depending on the nature of the project.

• Prepare, coordinate, and maintain regulatory submissions and technical documentation for our clients' products, including technical files, post-market surveillance, and clinical evaluation.
• Work with regulatory submissions, submissions, and dialogue with authorities and notified bodies.
• Support our clients in strategies for products regulated by regulations such as (EU MDR/IVDR, FDA, MDSAP, etc.).
• Work on business development for consulting services within RA. Contribute to recruitment, client meetings, and proposal work.

• Bachelor's degree in Life Science, biomedicine, biotechnology, medical technology, or equivalent.
• At least 2 years of experience in Regulatory Affairs or Quality within IVD or medical technology.
• Excellent collaboration skills, structure, and attention to detail.
• If you have worked in a consulting role, it is an advantage.
• Excellent communication skills in English, both spoken and written.
• Good knowledge of Swedish, both spoken and written.

Interested in learning more? Send in your CV, or contact us at SallyQ either Charlotte Duvefelt or Ellinor Crafoord.

About SallyQ

We are a company founded with the desire to build a competence company where customer value and people are at the center. We have extensive experience in recruitment and quality work within the Life Science industry. Our vision is to help innovative companies and people make as great a positive difference as they possibly can in the world. We believe in quality in everything from interaction, communication, delivery to relationships.