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

Hands-on Regulatory Affairs Expert
Sunmedic AB —Vellinge
- Heltid
- Engelska
- Masterexamen
- Kandidatexamen
6d
Technical Sales Manager Animal Nutrition – CEE & Balkans
Perstorp Group —Malmö
- Heltid
- Distansjobb
- Försäljning
- Forskning
- Masterexamen
Territory Manager Orthodontics
Straumann Group —Malmö
- Heltid
- CRM-program
- Försäljning
- Marknadsföring
Director Regulatory Affairs
Hansa Biopharma —Lund
- Heltid
- Kontor
- Masterexamen
- Kommunikationsfärdigheter
QC Analyst – Cleaning Verification & Validation (Helsingborg)
WeQuel —Helsingborg
- Engelska
Senior QA Manager Validation & Quality
Hansa Biopharma —Lund
- Heltid
- Kontor
- Masterexamen
- Kommunikationsfärdigheter
Senior Process Engineer - Camurus (Lund)
TOBLOR Consulting AB —Lund
- Heltid
- Engelska
- Masterexamen
HR Site Lead, LER
HEMOCUE AKTIEBOLAG —Ängelholm
- Heltid
- Engelska
- Kandidatexamen
- Företagsekonomi
14d
Software Engineers for Custom Object Training – Building the Engine and the Face of Custom AI, Lund
Axis Communications —Lund
- Heltid
- Masterexamen
- Databaser
- Kandidatexamen
BatMAX PostDoc at MAX IV (NanoCT)
Lunds universitet —Lund
- Doktorsexamen
- Engelska
- Kommunikationsfärdigheter
Commercial Sales Systems Coordinator
HemoCue —Ängelholm
- Heltid
- CRM-program
- Engelska
- Företagsekonomi
Lead Integration Architect, Lund
Axis Communications —Lund
- Heltid
- Organisationsförmåga
7d
Project Lead - Development
AutomationsPartner —Helsingborg
- Engelska
- Flexibel arbetstid
Sr. Project Manager – R&D
Nipro —Malmö
- Kontor
- Masterexamen
- Projektledning
Compliance & Validation Specialist
PolyPeptide Group —Malmö
- Engelska
- Masterexamen
- Kandidatexamen
Senior Outsourcing Manager - Camurus (Lund)
TOBLOR Consulting —Lund
- Engelska
- Masterexamen
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Solutions Engineer EMEA – AI & Analytics
Axis Communications —Lund
- Heltid
- Engelska
- Masterexamen
Global Business Compliance Manager
HemoCue —Ängelholm
- Heltid
- Kandidatexamen
- Företagsekonomi
Kvalitetsingenjör- Maskinprojekt till AutomationsPartner i Helsingborg
Qarat —Helsingborg
- Engelska
- Tidsplanering
- Flexibel arbetstid
ASIC SoC System Architect, Lund
Axis Communications —Lund
- Heltid
- Engelska
- Masterexamen
- Ledarskap

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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

Territory Manager Orthodontics

Director Regulatory Affairs

QC Analyst – Cleaning Verification & Validation (Helsingborg)

Senior QA Manager Validation & Quality

Senior Process Engineer - Camurus (Lund)

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Software Engineers for Custom Object Training – Building the Engine and the Face of Custom AI, Lund

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Project Lead - Development

Sr. Project Manager – R&D

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Senior Outsourcing Manager - Camurus (Lund)

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ASIC SoC System Architect, Lund

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

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