Sweden Job Openings
SallyQ AB
Regulatory Affairs Specialist
Årsta
October 24, 2024
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.
- 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.
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 Sally Q. 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.
New Job Alerts
AFRY
Fredrik söker en Senior Projektledare inom produktutveckling och produktion i Mälardalen
Stockholm
November 20, 2024
View Job DescriptionSway Sourcing Sweden AB
Scrum Master & Business Analyst - Malmö
Malmö
FULL TIME
November 20, 2024
View Job Description
Job Solution Sweden Consulting AB
CAM-beredare med erfarenhet av kompositmaterial
Linköping
FULL TIME
November 20, 2024
View Job Description
Business Sweden
Senior Advisor, Strategic Partnerships to GTI, Washington D.C.
Stockholm
November 20, 2024
View Job DescriptionCo-Worker Consulting Partner Sweden AB
Expert on Baseband Layer 2 Architecture
FULL TIME
November 20, 2024
View Job Description
Karolinska Institutet, doctoral positions
Doktorandplats inom klinisk epidemiologi med fokus på vaccination under graviditet
Solna
FULL TIME
November 20, 2024
View Job DescriptionLooking for similar job?
Danone
Regulatory Artwork Validator Sweden & Finland
Solna
PART TIME
October 25, 2024
View Job Description
Lilly
Patient Safety and Regulatory Associate/Sr. Associate
Stockholm
FULL TIME
November 7, 2024
View Job Description
Platform24
Senior Legal Compliance and Regulatory Counsel
Stockholm
October 23, 2024
View Job Description
Haeger & Carlsson | Executive Search & Interim AB
Director Regulatory Affairs - Diamyd Medical
Stockholm
November 5, 2024
View Job DescriptionKellyOCG Sweden AB
AstraZeneca CMC Regulatory Affairs Associate - through KellyOCG
Södertälje
FULL TIME
October 10, 2024
View Job DescriptionNew Job Alerts
AFRY
Fredrik söker en Senior Projektledare inom produktutveckling och produktion i Mälardalen
Stockholm
November 20, 2024
View Job DescriptionSway Sourcing Sweden AB
Scrum Master & Business Analyst - Malmö
Malmö
FULL TIME
November 20, 2024
View Job Description
Job Solution Sweden Consulting AB
CAM-beredare med erfarenhet av kompositmaterial
Linköping
FULL TIME
November 20, 2024
View Job Description
Business Sweden
Senior Advisor, Strategic Partnerships to GTI, Washington D.C.
Stockholm
November 20, 2024
View Job DescriptionCo-Worker Consulting Partner Sweden AB
Expert on Baseband Layer 2 Architecture
FULL TIME
November 20, 2024
View Job Description
Karolinska Institutet, doctoral positions
Doktorandplats inom klinisk epidemiologi med fokus på vaccination under graviditet
Solna
FULL TIME
November 20, 2024
View Job Description