Vacature: Quality & Regulatory Associate bij Technomed Engineering BV - Maastricht-Airport
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Quality & Regulatory Associate
Technomed Europe | 
Gezondheid / (Para)medisch / Zorg| 
Maastricht-Airport | 
40 uur 
HBO




Technomed Europe

  Gezondheid / (Para)medisch / Zorg
   Beek
  40 uur   
HBO



  • Is improving the quality of our company something you would enjoy, as well as being involved in product and document control?
  • Are you happy to dot the i's and cross the t's, but do you also know when 80% is sufficient?
  • Do you have a great affinity with the medical sector?

Three times yes?! Please read more...

Quality & Regulatory Associate

We believe technology can have a big impact on patients' lives. Therefore we are proud to get on your nerves! Our products transform a bio-electrical signal from patient to medical equipment to measure the nerve system on brain and muscle activities.

In this position you will be working in the business unit Technomed/Neurosign, headquartered in Maastricht-Airport (NL). Technomed/Neurosign is an expert in four business segments: Clinical NeuroPhysiology, IntraOperative NeuroMonitoring, Multiple Electrode Patches and Neurosign equipment. We deliver high quality operating room solutions for surgeons based globally. 

What is your role?
The Quality Assurance & Regulatory Affairs department is looking for a new colleague who is versatile, eager and structurised and good in setting priorities

In this position you will be dealing with Regulatory, as well as Quality activities. That makes this position very unique to develop yourself in both worlds. As a Quality person you will for example be identifying root cause analysis and subsequent corrective actions for products and processes (CAPA), and ensure timely communication with customers. From a Regulatory aspect, you will complete registrations in different countries according to set regulations.

In this position you will have a wide diversity of activities and responsibilities, just a few mentioned here:
  • Technomed is involved in worldwide registrations. You are the link to communicate with all relevant notified bodies and governments: US FDA, Health Canada and European Authorities.
  • You have a magnifying glass on our quality. You are responsible for document and design control. You coordinate, implement and monitor the activities needed to make sure all our products meet specific medical quality requirements.
  • You are a partner for our internal stakeholders. You exchange information on quality perspective on the most diverse (customer) projects in order to meet requirements.
  • You hang on with your claws and teeth in projects related to good document control, training management, internal auditing
  • Technomed is already aware of quality and regulatory requirements. But you can figure out how things can get even bigger here.

Make a long story short, do you wonder how you explain this to your friend and family? Then say: “Well, I ensure that all medical products Technomed produces are of high quality and safe for you and your family when used in hospitals all over the world.”

How do you handle this?

  • As a Quality & Regulatory Associate you are constantly busy with…. Getting the quality of documents to the highest needed level. Medical documents and information are your second nature and part of your Technomed life.
  • Your door is always open to your project colleagues.
  • You collect and check data to make decent and well-founded registration and administration.
  • You provide colleague with the necessary information and tools to reach the highest tops.

Who are you?

  • You have earned your stripes in document control for at least one year and preferable have a scientific Bachelor’s degree or experience in life sciences, (bio)medical, chemistry, pharmacy or other related.
  • Your knowledge and expertise is build up on quality management systems. The new MDR regulation, as well as MDSAP is no piece of cake, but you are familiar, trained and driven to apply this correctly.
  • English? YES! Dutch? Dat is handig! You make an impression with your English either orally and in writing.
  • Your smooth communication style gives you the advantage that you can level with all kinds of individuals and you are a team player in heart and soul.
  • Like a chameleon you like to change from one priority to the other. You are happy when you can dot the i’s, but you also know the pragmatic approach to see when 80% is also sufficient.
  • You learn quickly, are eager to develop and take proactivity of paramount importance.
  • You enjoy helping the organisation to level up. Offering added value: that is what you live for!

You do not match the job requirements exactly? We are not looking for the perfect non-existing candidate! You do have to possess the competences above and a great awareness and understanding of working in a high performance, hands-on medical company.

To a broader extension, these are nice-to-haves:
  • Knowledge of EMEA country regulations, U.S. FDA regulations, the Medical Devices Directive (93/42/EEC, as amended), and various Quality System Standards/Regulations/Laws, including but not limited to ISO 13485, etc.
  • Complex capital equipment systems.
  • Neuromodulation / Neurophysiology / Neuromonitoring / Nerve Monitoring, EEG or EMG.
  • Familiar with a 510K product launch in the US.


What is in it for you?

A job within Technomed is so varied that it never gets boring. Characteristics that you will experience:

  • A dynamic organization in full expansion, internationally oriented but with an absolute drive to maintain the mentality and atmosphere of a small organization. We are a down-to-earth, results driven organization with short lines of communication and quick decision making..  
  • We value a hands-on approach and allow you to excel, develop, create and implement your own expert knowledge that can be converted to the best results. We support talents to further develop their competences.
  • A passionate team that wants to join forces to develop business together.
  • A warm Technomed team that is eager to welcome you with open arms.
  • An organization that works on professionalisation and wants to improve continuously.
  • An active staff association that organises activities such as escape rooms, dinners, team building ...
  • Secondary employment conditions, such as: flexible working hours, 24 days of leave with expansion possibilities up to 30 days per year, travel allowance from the first km, holiday allowance, WGA insurance, WIA excedent insurance, pension scheme, bonus scheme etc.


How to apply
Interested in this position at Technomed Europe? Please send your CV and motivation letter by submitting your application by using our Online Application Form. For questions and more information about the Quality & Regulatory Associate vacancy, please contact Conny Henkens (Human Being Manager) on phone number 0031 (0)43 408 68 78. Website: Go to website

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Contact informatie
Technomed Europe
t.a.v. Conny Henkens
P.O. Box 239
6190 AE Beek

Tel: 0031 (0)43 408 68 78
Website: Ga naar website