Regulatory Affairs Specialist

Do you thrive in a dynamic role, ensuring accuracy and compliance in Regulatory Affairs? Do you enjoy working with many internal interactions and where no day looks like the other?

If so, this opportunity is perfect for you!

Diagnostic products play a crucial role in advancing global health and enhancing quality of life. Devyser is a leading company in the diagnostic sector, dedicated to advancing diagnostic technologies and improving patient care. The QA/RA team at Devyser is growing and we are now seeking a Regulatory Affairs Specialist to join us and support our efforts in ensuring that our diagnostic products meet all relevant international and local regulations and enabling them to reach the market successfully.

The position: As the Regulatory Affairs Specialist you will play a key role in ensuring that Devyser’s diagnostic products comply with regulatory requirements globally. You will work closely with cross-functional teams, such as R&D, sales, marketing and QA to support product registrations and regulatory submissions in compliance with IVDR (EU), FDA (US), and other international regulations and standards. This position is crucial in helping our products reach the market efficiently while maintaining high compliance standards.

Key responsibilities:

• Prepare and coordinate regulatory submissions for IVD products, including technical files, clinical evaluation documents etc.
• Maintain and update regulatory documentation to support product registration, renewals, and compliance with changing regulations.
• Assist together with the team in managing communication with regulatory authorities and respond to inquiries, inspection requests, and follow-up actions.
• Stay updated on changes in global IVD regulations, such as IVDR and FDA, and provide guidance to internal teams on regulatory impact.
• Collaborate with internal departments like R&D, Quality, and Marketing to ensure compliance throughout the product lifecycle.
• Participate in post-market surveillance activities and ensure ongoing compliance with regulatory standards after product launch.

Qualifications:

• Bachelor’s degree in life sciences, biomedical engineering, or a related field.
• 2+ years of experience in Regulatory Affairs or Quality within IVD
• Strong collaboration- and organization skills and attention to detail.
• Excellent communication skills in English, both verbal and written.
• Good skills in Swedish, both spoken and written.

Why Join Us:

You’ll be part of an energetic and supportive team, deeply committed to Devyser's mission of delivering easy-to-use diagnostic products to the global market.

Your workdays will be spent in a state-of-the-art office in Årsta, in a specialist role with many of interactions in a growing company.

Application:

In this recruitment Devyser is collaborating with SallyQ. If you are interested in the position and want further information, contact Senior Recruitment Consultant Ellinor Crafoord 079-3554257 or ellinor.crafoord@sallyq.se

Application deadline: 12th November 2024

About Devyser

Based in Stockholm, Sweden, Devyser is a pioneer in diagnostic kits and solutions for advanced DNA testing. Our goal is to eliminate tedious protocols and streamline laboratory workflows with simple, fast, and easy-to-use solutions. So, all patients receive a correct diagnosis and faster treatment in the shortest time possible.

Devyser is a leading company in the diagnostic sector, dedicated to advancing diagnostic technologies and improving patient care.