Regulatory Medical Device - 4719

30-3-2020 braine-l'alleud
bedrijfsprofiel

Our client is a global biopharmaceutical company focusing on creating value for people living with neurology and immunology conditions.

jobomschrijving

If you are a Technical Writer who's looking for a new challenge in a Pharmaceutical company, feel free to apply !

megane.libert@cx.ausy.be / +32(0)497/61.85.75

Mégane Libert

The Pipeline Device Development department of our client's company is recruiting a Technical Writer.

The primary goal of the function is to author reports and templates and manage documentation for device development team, thus supporting activities relating to the device development, transfer, assembly process qualification and clinical/commercial manufacturing support. They will work in a team environment, collaborating with various quality, regulatory, scientific, clinical and manufacturing experts. They will author and review relevant documents that support regulatory license applications and hence have to be of a very high standard. The data to be summarized in the reports will be collected from electronic and physical repositories, verified, cleaned, analyzed and visualized. Based on this, the writer will then generate scientific reports supporting the design history file  and regulatory filings (Development and Technical Reports in English) and contribute to the preparation of regulatory submissions with business partners. The reports will be written in English. The technical writer will manage their review and approval in the appropriate electronic document management system. The candidate will also contribute to the data review of the relevant CMC sections of regulatory dossiers.

The main activities of this function will be:

  • Source data from batch records, lab books, data management systems and existing reports, evaluating the information, and generate summary reports
  • Author device development protocols, reports, risk assessment and templates in English
  • Verify data
  • Manage documents within systems
  • Data mine from physical and electronic repositories
  • Manage, analyze and visualize data
  • Generate training materials based on lessons learned exercises
  • Present/discuss documentation in project team meetings
  • Liaise with other departments or external partners to ensure documentation meets stakeholder’s needs (quality, regulatory, commercial manufacturing, etc…)

All these activities will be performed in compliance with Health, Safety & Environment (HSE) as well as Quality policies and standards and with the regulatory requirements for each development phase of the products.

jouw aanbod

  • Minimum of 3 years working in the pharmaceutical/biologics/medical device industry
  • Operational GMP or quality experience would be a distinct advantage
  • Practical understanding of ISO13485, 21CFR820, 21CFR210/211, 21CFR4, ISO14971, ICHQ9, MDR requirements
  • Demonstrate ability to independently analyse data and information to draw conclusions and make effective decisions
  • Must be able to identify and assess risks together with proposing corrective actions within area of expertise
  • Help others solve problems in a creative and practical way through development of solutions from innovative problem solving activities
  • US and EU knowledge of pharmaceutical and medical devices regulations together with quality principles and techniques. 
  • Experience in GMP and Regulatory Requirements within the pharmaceutical industry
  • Experienced in CAPA management
  • Must possess good interpersonal, verbal, and written communication skills and be able to confidently present information at interdepartmental
  • Root cause analysis and risk management/assessment skills will be a distinct advantage

wat bieden wij?

A mission until the end of the year (extension possible) as consultant at our client with the possibility of a permanent contract at Ausy.

We offer an attractive salary with extra-legal advantages : 

  • Group insurance
  • Hospitalisation insurance
  • Meal vouchers of 7 euros gross per working day
  • Reimbursement km or company car 
  • Monthly allowance (50 euros net per month)
  • A 13th month
  • Training
  • Etc

A rate as freelance is also possible !

overzicht
functie
administratief medewerker (m/v)
jobtype
voltijds, freelance
contracttype
lange opdrachten
referentie
CXRSP-89254
contact informatie
Mégane Libert
megane.libert@cx.ausy.be 02 474 60 16
02 474 60 16