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

Hands-on Regulatory Affairs Expert
Sunmedic AB —Vellinge
- Heltid
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Technical Sales Manager Animal Nutrition – CEE & Balkans
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Hansa Biopharma —Lund
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WeQuel —Helsingborg
- Engelska
Senior Clinical Data Manager
BC Platforms —Lund
- Deltid
- Forskning
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Senior Software Engineer
Aveva —Malmö
- Heltid
- Kontor
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Axis Communications —Lund
- Heltid
- C++
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Senior Process Engineer - Camurus (Lund)
TOBLOR Consulting —Lund
- Engelska
- Masterexamen
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Kvalitetsingenjör automation och datoriserade system, Malmö
KeyPlants AB —Malmö
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MES Engineer
HemoCue —Ängelholm
- Heltid
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HemoCue —Ängelholm
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Lunds universitet —Lund
- Jour / Beredskap
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Software Engineer – Axis Device Management SaaS, Lund
Axis Communications —Lund
- Heltid
- Masterexamen
- Kandidatexamen
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Senior Mechanical Engineer
Sigma Group —Lund
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Schneider Electric —Lund
- Heltid
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Sigma Group —Lund
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Production of supplements / Tillverkning av kosttillskott / English Below
Swedish Nutra AB —Malmö
Praktisk erfarenhet av tillverkning av kosttillskott, läkemedel eller kosmetiska produkter. Vi söker en ny medarbetare till vår produktionsvdelning för flytande…
Timvikarier till äldreomsorgen
Hässleholms kommun —Hässleholms kommun
När du klickat på länken får du svara på några frågor - CV behövs inte. Arbete i hemmet med äldre och personer med funktionsnedsättning | Polismyndigheten.

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

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Hands-on Regulatory Affairs Expert

Sunmedic AB
Vellinge

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Jobbinformation

Tillsvidare | Heltid
6 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.

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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)

Senior Clinical Data Manager

Senior Software Engineer

Software Engineer - Edge Video Analytics

Senior Process Engineer - Camurus (Lund)

Kvalitetsingenjör automation och datoriserade system, Malmö

MES Engineer

Affärscoach med inriktning på kapitalanskaffning och finansiering

HW Designer Electronics

Machine operator 5 skift - Vikariat

Detector Software Engineer

Software Engineer – Axis Device Management SaaS, Lund

Senior Mechanical Engineer

Testingenjör

Senior Cloud Engineer

Maskiningenjör/ Processingenjör inom vattensystem

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