Based in Stockholm, Sweden, Devyser is a pioneer in diagnostic kits and software 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.
About the role
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.
Your duties in the role include but are not limited to:
- 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.
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.
What you are offered
Our core values are Simplicity Relevance Empathy. Devyser's core values are implicated in our vision and mission but are also the basis of our company culture. At Devyser you are offered an environment where your growth and innovation are encouraged. The surrounding team is made up of dedicated people with exceptional expertise in their areas. You are part of something great.
We care about our employees and therefore offer a benefit package to reflect this, with advantageous pensions, insurances, wellness contribution, advance holiday and benefits such as regular health check-ups and chiropractor treatments at the office.