Profil #206890

As a structured and organized MSc. graduate in Health Informatic, I can with my previous experience in the regulatory field and vigilance reporting. Using my flairs, I can disseminate business plans according to the company’s internal regulation. With my basic knowledge of legislation for medical devices and post market, I can contribute to quali
QA RA Medical Devices vigilance reporting legislation  
Opdateret 03. april 2019
Min uddannelse
2019 - 2019

Kurser, efteruddannelse og andet

Anden uddannelsesinstitution i Danmark

INTERN AUDIT AF VIRKSOMHEDENS PROCESSER, FORCE TECHNOLOGY
From this course I learned the purpose of conducting internal audits using audit and behavior technics. I got knowledge of the formal requirements from ISO 19011 as well as reporting non-conformances.
Uddannelsesområde: Jura
Periode: januar 2019 - januar 2019
2019 - 2019

Kurser, efteruddannelse og andet

Anden uddannelsesinstitution i Danmark

QUALITY MANAGEMENT SYSTEM ISO 13485, PREVENTIA AB

From this course I got the full introduction and guidance documents to the ISO 13485:2016 “Quality Management System”. I learned how to interpretation the clauses and see the patterned for good documentation practice.
Uddannelsesområde: Jura
Periode: januar 2019 - januar 2019
2016 - 2018

Cand.scient. i IT og Sundhed

Københavns Universitet

My Master's degree program has given me an understanding of the progress and processes patients and health professionals are going through. I have learned new qualitative and quantitative analyzes to know and expand my knowledge of programming languages. And gained insight into how the economic side of the Danish welfare system is connected.
Uddannelsesområde: Medicinal & Sundhed
Periode: september 2016 - juni 2018
2018 - 2018

Kurser, efteruddannelse og andet

Anden uddannelsesinstitution i Danmark

My RA officer studies gave me the bacis knowlegde for understanding the legislation involving medical devices. The main focus point of this studie was on the procedure for quality management systems according to ISO EN 13485:2016, classification of medical devices according to Annex VIII and risk management 14971:2009.
Uddannelsesområde: Medicinal & Sundhed
Periode: marts 2018 - maj 2018
Min erhvervserfaring
2018 - 2019

Quality System Audits

Cook Medical Denmark

In the timeframe that I worked for Cook Medical, I was an observer during conduction of Internal Audits. I supported audit team during the preparation by preparing the nessesary documents. Likewise I supported and participated in the post-work by preparing the audit report for the de-briefing of the schedualed audit based on the follow-up on finding.

My support was based on having an oversight of regulatory compliance within the Quality Management System (ISO 13485, MDD 93/42/EEC, FDA 21 CFR, Part 11 and FDA 21 CFR, Part 820)
Arbejdsområde: Medicinal & Sundhed
Periode: december 2018 - marts 2019
2018 - 2018

Project Associate

Medidee

Throughout my time at Medidee, I participated in a number of projects that affected all aspects of MDR compliance.

Among other things, some of my tasks included compliance with national rules for registered products in EU countries as well as classifying products according to Annex VIII from MDR. I also had the task of updating QMS in relation to ISO EN 13485: 2016.

I have gained a basic knowledge of the following medical device standards:
  • ISO EN 13485:2016
  • ISO EN 14971:2009
  • ISO EN 11608-1
    • - IEC 60601
    Arbejdsområde: Medicinal & Sundhed
    Periode: juni 2018 - november 2018
    2015 - 2018

    Studentworker

    Siemens Healthcare

    As part of my work in Siemens Healthcare A/S, I stood for the continuously updating and vigilance to secure that we as a firm was compliant with the national and international recruitments and laws for safe handling of medical devices including in vitro. I had the responsibility for knowledge dissemination to customers of medical devices and reporting events to the authorities.
    Arbejdsområde: Administration
    Periode: april 2015 - juni 2018
    2014 - 2016

    Salgskonsulent

    Tupperware Nordic

    As part of my work as a sales consultant for Tupperware Scandinavia.
    I was responsible for arranging and organizing each product demonstration.
    By continuously putting my self in a learning situation I expanded my product knowledge and was thereby able to give my customers and individual guidance that fitted there needs.

    By doing so I continuously expanded my clientele and my abilities to disseminate in a structured knowledge-based performance.
    Arbejdsområde: Salg
    Periode: maj 2014 - februar 2016
    Mine kompetencer
    Evner
    fda 21 cfr part 11 fda 21 cfr part 820 internal audits iso 13485:2016 iso 19011 kritisk tænkende mdd 93/42/eec mdr medical devices non-conformance reporting (ncr) quality assurance (qa) regulatory affaires (ra) regulatory compliance vigilance
    Sprog på arbejdsniveau
    dansk engelsk
    Mine præferencer
    Jobtype
    Deltidsjob Fuldtidsjob
    Arbejdsområde
    Indkøb Jura Medicinal & Sundhed
    Geografi
    Nordsjælland Storkøbenhavn
    Lønønske
    35.000 DKK / måned
    Læs mere / links
    https://www.linkedin.com/in/id...
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