Requirements

Required education level
Ad. Federal PET / Fed. PET Diploma, Bachelor, Master
Required experience
Between 3 and 5 years
Required language knowledge
English German
Required skills
Compliance English Medical Devices German MEDICAL DEVICES compliance Risk Management GERMAN medical devices Switzerland german english Medical devices Dental quality assurance registration ISO 13485 dental 21 CFR 820 Quality Assurance German ENGLISH risk management Registration Quality assurance switzerland MDD Risk management MDR technical file QUALITY ASSURANCE COMPLIANCE SWITZERLAND LABELLING Labelling labelling Regulatory Affairs conformity assessment

Details

Location
Other countries
Term of employment
Full time
Sector
Medical technology
Professions
Regulatory Affairs Research & Development / Labor...

Description

Regulatory Affairs Manager - Swiss MedTech - English/German

Located within the German speaking area of Switzerland with excellent transport connections into surrounding countries, our client is a medium sized Swiss manufacturer of biomaterials and products for Dental use. Now under the care of a global company and with growth on their mind, a recruitment drive is underway, and with Regulatory Affairs Manager on top of the list of their priorities.

Required background and experience:

  • A degree in the Lifesciences, engineering, or medicine, with at least 3 years industry experience (including Medical devices) in international regulatory affairs submissions - US/Canada, Middle East & Africa, Asia-Pacific all of interest
  • Knowledge of EU medical device regulations wrt product classification, definition of applicable standards, conformity assessment procedures. Knowledge of other regulations such as US FDA & Japan JPAL are also beneficial
  • German language to at least advanced reading and understanding, English essential both written and spoken. Further languages are a plus

Daily tasks will be broad

  • Advising research & development and stakeholders on the interpretation of current regulatory requirements and updates, throughout the device lifecycle, and leading their implementation
  • Ensuring completeness of technical documentation of the products, and it's compliance to medical device regulatory requirements
  • Responsibility for the regulatory content of product-related information and its release
  • Conducting conformity assessment procedures for the products and initiating the preparation of the declaration of conformity
  • Support for international registration submissions
  • Risk Assessment & Audit support will benefit from prior Quality Assurance experience

The role does not involve line management nor is it specifically strategy focused, however prior experience in device classification and strategic involvement will be beneficial, and leadership responsibilities could be an option in the future as the team expands. The company does pride itself on continuing education.

If this role seems a good fit, please contact me NOW on 0041 43 50 80 817 for a confidential discussion of this opportunity, and send in your CV in WORD format with employment records (ArbeitsZeugnisse) and Training certifications to a.boroky@nonstopconsulting.com

The role is quite urgent and interviews will be arranged at short notice. Benefits including company pension, health package, flexible working hours, and continuing education programs.

KEY WORDS: Switzerland, Quality Assurance, Compliance, Medical Devices, German, English, 21 CFR 820, MDR, MDD, ISO 13485, Regulatory Affairs, registration, technical file, labelling, Risk Management, Dental, Medical Device jobs, Nonstop recruitment, conformity assessment, CE Mark, R&D, Research & Development, health authorities, notified body, Medical Device jobs, Nonstop recruitment

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in Switzerland, Luxembourg, the Czech Republic, UK, Romania, and the USA, and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.

NonStop Consulting
Oct 5, 2021

Contact info

NonStop Consulting
Andrew Boroky
p0w yw y- z7 )y( 07g
Not available