Anja Bengtzelius
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Anja Bengtzelius Email & Phone Number

Quality System and Regulatory Affairs Manager at Wellspect HealthCare
Location: Greater Gothenburg Metropolitan Area, Sweden 9 work roles 3 schools
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Current company
Role
Quality System and Regulatory Affairs Manager
Location
Greater Gothenburg Metropolitan Area, Sweden
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Who is Anja Bengtzelius? Overview

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Anja Bengtzelius is listed as Quality System and Regulatory Affairs Manager at Wellspect HealthCare, a with 723 employees, based in Greater Gothenburg Metropolitan Area, Sweden. AeroLeads shows a matched LinkedIn profile for Anja Bengtzelius.

Anja Bengtzelius previously worked as Quality System & Regulatory Affairs Manager at Wellspect Healthcare and Principal Regulatory Affairs Specialist at Cochlear. Anja Bengtzelius holds Master Of Science (Ms), Chemical Engineering from Chalmers Tekniska Högskola.

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Wellspect HealthCare

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About Anja Bengtzelius

Anja Bengtzelius is a Quality System and Regulatory Affairs Manager at Wellspect HealthCare. She possess expertise in v&v, design verification testing, design control, medical devices, test planning and 3 more skills.

Listed skills include V&V, Design Verification Testing, Design Control, Medical Devices, and 4 others.

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Anja Bengtzelius's current company

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Wellspect HealthCare
Wellspect Healthcare
Quality System and Regulatory Affairs Manager
Gothenburg, SE
Website
Employees
723
AeroLeads page
9 roles

Anja Bengtzelius work experience

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Quality System & Regulatory Affairs Manager

Mölndal, Västra Götaland, Sverige

Principal Regulatory Affairs Specialist

Mölnlycke, Västra Götaland, Sverige

Mar 2022 - Feb 2024

Quality And Regulatory Affairs Consultant

Jonsered

The work involve product registrations for different markets, quality assurance, verification, validation and product risk management for medical devices.

Oct 2015 - Mar 2022

Test Leader At The R&D Department

Mölnlycke

The work involved homecare ventilators and sleep therapy products. Both projects for new product introduction and engineering changes for existing products were included in the job. I worked with verification, validation and product risk management. My main responsibility were verification and my essential tasks were:- Creation of plans, test procedures and reports.- Development and improvement of test methods and test-setups for verification.- To analyze requirements/technical reviews.- Ensure traceability from requirements to performed tests and product risk.- Manage design defects in accordance with design control.- Product risk analysis.

Sep 2011 - Aug 2015

Process And Validation Engineer

Worked with process issues and process validation in turnkey contracts for pharmaceutical industry.

Sep 2007 - Aug 2011

Process And Validation Engineer

Åf

Worked with process issues and process validation in turnkey contracts for pharmaceutical industry.

Feb 2005 - Sep 2007

Biomedical Scientist

Mölndal

Performed different microbiological analyses.

Aug 2003 - Feb 2005

Teacher

Vällsjöskolan, Gällkvistskolan, Mariebergsskolan & Lundabyn

Mölnlycke, Skara & Lundsbrunn

Jan 1996 - Dec 1997
Team & coworkers

Colleagues at Wellspect HealthCare

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3 education records

Anja Bengtzelius education

FAQ

Frequently asked questions about Anja Bengtzelius

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What company does Anja Bengtzelius work for?

Anja Bengtzelius works for Wellspect HealthCare.

What is Anja Bengtzelius's role at Wellspect HealthCare?

Anja Bengtzelius is listed as Quality System and Regulatory Affairs Manager at Wellspect HealthCare.

Where is Anja Bengtzelius based?

Anja Bengtzelius is based in Greater Gothenburg Metropolitan Area, Sweden while working with Wellspect HealthCare.

What companies has Anja Bengtzelius worked for?

Anja Bengtzelius has worked for Wellspect Healthcare, Cochlear, Mediteq, Breas Medical, and Deltatec Ab.

Who are Anja Bengtzelius's colleagues at Wellspect HealthCare?

Anja Bengtzelius's colleagues at Wellspect HealthCare include Pernilla Sidlo, Anders Tennby, Rachel Oncay, İlker Demirel, and Danilo Sciutto.

How can I contact Anja Bengtzelius?

You can use AeroLeads to view verified contact signals for Anja Bengtzelius at Wellspect HealthCare, including work email, phone, and LinkedIn data when available.

What schools did Anja Bengtzelius attend?

Anja Bengtzelius holds Master Of Science (Ms), Chemical Engineering from Chalmers Tekniska Högskola.

What skills is Anja Bengtzelius known for?

Anja Bengtzelius is listed with skills including V&V, Design Verification Testing, Design Control, Medical Devices, Test Planning, Risk Management, Iso 14971, and Regulatory Affairs.

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