20 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
Agile Project Leader, Lund
Axis Communications —Lund
- Heltid
- Masterexamen
- Kandidatexamen
- Agile
6 tim
Director Regulatory Affairs
Hansa Biopharma —Lund
- Heltid
- Kontor
- Masterexamen
- Kommunikationsfärdigheter
QC Analyst – Cleaning Verification & Validation (Helsingborg)
WeQuel —Helsingborg
- Engelska
Senior Clinical Data Manager
BC Platforms —Lund
- Deltid
- Forskning
Ansök direkt
9 tim
ASIC SoC System Architect, Lund
Axis Communications —Lund
- Heltid
- Engelska
- Masterexamen
- Ledarskap
Technical Director to MAX IV
Lunds universitet —Lund
- Engelska
- Forskning
- Masterexamen
iOS Engineer – UI / Application Layer
Needefy AB —Malmö
- Masterexamen
- Kandidatexamen
- Kommunikationsfärdigheter
Software developer within the AI and Analytics Department, Lund
Axis Communications —Lund
- Heltid
- Kontor
- Masterexamen
- C++
11d
Manufacturing Associate I
Repligen Corporation —Lund
- Heltid
- Engelska
Manufacturing Associate
Repligen Corporation —Lund
- Heltid
- Engelska
Affärsdriven Controller med CFO-potential till AutomationsPartner
Qarat —Helsingborg
- Finans
- Redovisning
- Företagsekonomi
Embedded AI Engineer, Lund
Axis Communications —Lund
- Heltid
- Masterexamen
- Linux
- Python
ASIC SoC Security Architect, Lund
Axis Communications —Lund
- Heltid
- Engelska
- Masterexamen
Senior Embedded Software Engineer
Cyberway AB —Malmö
- Heltid
- Engelska
- C++
- Python
Training Design Specialist ATCO to Malmö
Entry Point North —Malmö
- Projektledning
Affärsdriven Controller med CFO-potential till AutomationsPartner
Q.R.T QARAT AB —Helsingborg
- Heltid
- Finans
- Redovisning
- Företagsekonomi
6d
Product Image Engineer, Lund
Axis Communications —Lund
- Heltid
- Masterexamen
- C++
- Linux
13d
Field Service Engineer - Remote from Lund/Malmö area
Molecular Devices —Ängelholm
- Heltid
- Distansjobb
- Kunskap om mekanik
- Betald semester

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

Jobb som Ios Developer i Malmö

Jobb som Software Engineer i Lund

Jobb som Mall Of Scandinavia i 114 58 Stockholm

Jobb som Head Of Business Control i Stockholm

Jobb som Director Of Finance i Stockholm

Jobb som World Of Volvo i Göteborg

Jobb som Solution Architect i Stockholms Län

Jobb som Enterprise Architect i Stockholm

Jobb som Software Testing i Göteborg

Jobb som Rf Engineer i Göteborg

Jobb som Senior Software Engineer i Stockholm

Jobb som Senior Software Engineer i Jönköping

Jobb som Integration Engineer i Järfälla

Jobb som Senior Software Engineer i Luleå

Jobb som Senior Redovisningsekonom i Stockholms Län

Jobb som Senior Software Engineer i Göteborg

Jobb som Embedded Hardware i Stockholm

Jobb som Architect i Malmö

Jobb som Training Specialist i Stockholms Län

Jobb som Paid Media Specialist i Stockholm

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

Agile Project Leader, Lund

Director Regulatory Affairs

QC Analyst – Cleaning Verification & Validation (Helsingborg)

Senior Clinical Data Manager

ASIC SoC System Architect, Lund

Technical Director to MAX IV

iOS Engineer – UI / Application Layer

Software developer within the AI and Analytics Department, Lund

Manufacturing Associate I

Manufacturing Associate

Affärsdriven Controller med CFO-potential till AutomationsPartner

Embedded AI Engineer, Lund

ASIC SoC Security Architect, Lund

Senior Embedded Software Engineer

Training Design Specialist ATCO to Malmö

Affärsdriven Controller med CFO-potential till AutomationsPartner

Product Image Engineer, Lund

Field Service Engineer - Remote from Lund/Malmö area

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