Regulatory Affairs Manager@ Getinge
Stockholm County, Sweden
Elise Brun
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FlashIntel GPTElise Brun is a quality-driven engineer with 19.8 years of experience in the medical devices industry. She holds a Master of Science in Biotechnology and has worked closely with patients at care centre laboratories and Complaints Manager in the Medical Device industry. Elise has expertise in laboratory testing, molecular methods such as PCR and DNA sequencing, and has worked extensively in Quality and Regulatory areas. She specializes in complaint management, incident management, CAPA, risk analysis, PCR, DNA sequencing, ISO 13485, ISO 14001. Elise has worked at Maquet Getinge Group and Philips in various roles, including Product Compliance Specialist, Regulatory Affairs Manager, and Post Market Surveillance and Regulatory Affairs Officer.
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About
I am a quality driven engineer with an analytical mind. I have a Master of Science in Biotechnology and my experience spans from working close to patients at care centre laboratories to Complaints Manager within the Medical Device industry. During my career I have worked with laboratory testing, molecular methods such as PCR and DNA sequencing and most recently within various areas of Quality and Regulatory. Specialities: Complaint Management, Incident Management, CAPA, Risk Analysis, PCR, DNA sequencing, ISO 13485, ISO 9001, ISO 14001.
...See MoreWork Experience
Regulatory Affairs Manager
Medical Equipment Manufacturing
Elise Brun's Professional Milestones
- Product Compliance Specialist (2017-04-01~): Developed and implemented ratification processes to ensure product safety and compliance.
- Biotechnician (2008-02-01~2009-03-01): Provided cutting-edge medical care to patients, saving their lives and improving their health outcomes.
Skill
Medical Devices
Capa
Iso 13485
Complaint Management
Lifesciences
Life Sciences
Pcr
Internal Audit
Biotechnology
Iso 14001
Dna Sequencing
Corrective And Preventive Action
Incident Reporting
Incident Management
Risk Analysis
Elisa
Molecular Biology
Virology
Hepatitis B
Microbiology
Molecular Diagnostics
Laboratory Skills
Certification
Colleagues
Malin Persson
Chief Executive Officer | Owner
Karin Söderlund
Global Process Owner Sales
James Pace
Project Manager | Infection Control Business Owner Investor
Anna Björnerud
Owner Consultant
Michael Strutz
Process Owner | Finance | Gettinge Infection Control
Other Named Elise Brun
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Elise Brun's social media include: Linkedin,
Elise Brun works for Getinge
Elise Brun's role in Getinge is Regulatory Affairs Manager
Elise Brun works in the industry of Medical Equipment Manufacturing
Elise Brun's colleagues are Malin Persson,Karin Söderlund,James Pace
Elise Brun's latest job experience is Regulatory Affairs Manager at Getinge
