9 bästa jobben som life science i skåne län (Rekryterar nu!)

Hands-on Regulatory Affairs Expert
Sunmedic AB —Vellinge
- Heltid
- Engelska
- Masterexamen
- Kandidatexamen
7d
Technical Sales Manager Animal Nutrition – CEE & Balkans
Perstorp Group —Malmö
- Heltid
- Distansjobb
- Försäljning
- Forskning
- Masterexamen
Director Regulatory Affairs
Hansa Biopharma —Lund
- Heltid
- Kontor
- Masterexamen
- Kommunikationsfärdigheter
QC Analyst – Cleaning Verification & Validation (Helsingborg)
WeQuel —Helsingborg
- Engelska
Sr. Project Manager – R&D
Nipro Europe Group Companies —Malmö
- Kontor
- Masterexamen
- Projektledning
Senior Clinical Data Manager
BC Platforms —Lund
- Deltid
- Forskning
Ansök direkt
1d
Senior Cloud Engineer
Schneider Electric —Lund
- Heltid
- Skrivkunskaper
- Engelska
- Kontor
- Betald semester
- Föräldraledighet
Maskiningenjör/ Processingenjör inom vattensystem
Sigma Group —Lund
- Projektledning
AOSP /Android Developer
ALTEN Sverige —Lund
- Masterexamen
- C++
- Kandidatexamen
16 tim

Discover related jobs

Based on your search for life science jobs.

Staff scientist in NMR Spectroscopy
Lunds universitet —Lund
A full-time research engineer (facility manager) is already responsible for servicing the NMR centre. Qualified service to users of the NMR centre, including…
Director Regulatory Affairs
Hansa Biopharma —Lund
As Director Regulatory Affairs you will report to the Chief Regulatory Affairs Officer, and will be a part of our Regulatory Affairs and Clinical Reporting…

Jag vill få den senaste jobbevakningen för life science i skåne län

Genom att logga in på ditt konto godkänner du SimplyHireds användarvillkor och samtycker till vår cookie- och sekretesspolicy.

Utforska jobb på fler orter

life science jobs near skåne län

Hands-on Regulatory Affairs Expert

Sunmedic AB
Vellinge

Ansök nu

Jobbinformation

Tillsvidare | Heltid
7 dagar sedan

Kvalifikationer

Engelska
Masterexamen
Kandidatexamen
Övervakning
Organisationsförmåga

Fullständig jobbeskrivning

Sunmedic is a medical device company focused on developing safe and effective products. We are looking for a hands-on Regulatory Affairs Expert who can take ownership of technical documentation, ensure regulatory compliance, and work closely with quality and development teams.
What you will do

Prepare, maintain, and update technical files and regulatory documentation in line with EU MDR and other applicable regulations.
Handle regulatory submissions (EU MDR) and manage lifecycle activities including updates and variations.
Support and maintain the quality management system (ISO 13485), including quality control documentation and records.
Review and assess design changes, labeling updates, and material changes for regulatory impact.
Collaborate with Quality Assurance and R&D teams to ensure technical documentation is complete, accurate, and audit-ready.
Prepare for and support audits and inspections by notified bodies and competent authorities.
Contribute to post-market surveillance activities and the preparation of related reports (e.g., PMCF, PSUR).
Monitor regulatory updates and implement necessary changes in technical files and quality documentation.

Who you are

A practical and detail-oriented regulatory professional who enjoys working directly with technical files and documentation.
Comfortable working in a fast-paced environment where you need to deliver concrete regulatory outputs.
Proactive in identifying compliance gaps and implementing practical solutions.
Clear communicator who can work effectively with Quality, R&D, and external auditors.

What you have

Bachelor’s or Master’s degree in Life Sciences, Engineering, or a related field.
At least 2 years of ,hands-on regulatory affairs experience, in the medical device industry.
Solid experience preparing and maintaining, technical files, and working within a quality management system (ISO 13485).
Good knowledge of EU MDR requirements and regulatory submissions.
Strong organizational skills and attention to detail when managing documentation and multiple tasks.
Proficiency in English (written and spoken).

Nice to have:

Experience with post-market surveillance and clinical evaluation reports.
Familiarity with US FDA 510(k) or UK MDR submissions.
Previous involvement in audits or inspections.

What we offer

Competitive salary and benefits.
Flexible working arrangements.
The opportunity to work closely with product development and quality teams on real regulatory deliverables.

How to apply
Please send your CV and a short cover letter describing your experience with technical files, quality systems, and regulatory submissions, to [email protected]. Mention any specific documentation or projects you have worked on.

Ansök nu

Förfina din sökning

life science jobb i skåne län

Hands-on Regulatory Affairs Expert

Technical Sales Manager Animal Nutrition – CEE & Balkans

Director Regulatory Affairs

QC Analyst – Cleaning Verification & Validation (Helsingborg)

Sr. Project Manager – R&D

Senior Clinical Data Manager

Senior Cloud Engineer

Maskiningenjör/ Processingenjör inom vattensystem

AOSP /Android Developer

Discover related jobs

Jag vill få den senaste jobbevakningen för life science i skåne län

Related Searches

Utforska jobb på fler orter

Verktyg för jobbsökare

Arbetsgivarverktyg

Bläddra bland

Håll kontakten