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Pre-Market QARA Specialist

Date: Dec 1, 2021

Location: Mortsel, BE

Company: AGFA

Pre-Market QARA Specialist

 

For our Radiology Solution Division, we are looking for a Pre-Market QARA Specialist.

You’ll be part of the Pre-Market Team within the QARA Department. QARA is within the Radiology Solution Division (RSD) responsible for governing the knowledge about and ensuring compliance to the regulatory requirements applicable for medical devices and to maintain the quality management system of the company. As a result, the functions within QARA have an international character. The pre-market department focuses to ensure compliance of the medical devices over the full life cycle.

 

As Pre-Market QARA Specialist you’re responsible for:

 

Product Development:

  • Ensuring the quality and regulatory requirements during development of medical devices and after the product launch
  • Creating and maintaining of Key Regulatory Deliverables during the design process
  • Performing and moderating the medical risk analysis during the development
  • Gaining knowledge about one or more subject matters within medical regulations/standards

 

Product Launch:

  • Manage global registration activities of the medical devices based on the Marketing Launch Plan
  • Support the global QARA network during local registration activities

 

Audit:

  • Execute internal audits and audits at critical suppliers
  • Support the QARA team during external audits (CE, FDA, MDSAP, …)

 

Your Profile:

 

  • You have an academic degree (Biomedical Engineer, Chemical Engineer, …) or equivalent experience.
  • You have experience in a regulated environment – preferably medical devices, IVD or pharmaceutical.
  • You are an outspoken team player with very strong analytical skills.
  • You have good verbal and written communication skills, both within the company as with externals.
  • You work autonomously and are problem solving oriented. You’re able to balance decisions against possible risks.
  • You are willing to continuously gain knowledge
  • You are willing to travel
  • You speak and write English fluently. Knowledge of additional languages is a plus.
  • Knowledge of quality standards and requirements is a plus. (MDR, ISO 13485, ISO 14971, IEC 60601, 21 QSR 820, …)
  • Experience with project management is an added value.

 

What we offer now and in the future

 

  • A dynamic global organization with a history of innovation and strong product portfolio.
  • A challenging environment combined with a supportive management structure.
  • Career development and growth.
  • A competitive salary and benefit package.
  • A friendly work environment surrounded by dedicated and professional colleagues.

 
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