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USG Professionals Science

International Regulatory Affairs Specialist Medical Devices

Zaventem
Staat 20 dagen op Jobat.be

International Regulatory Affairs Specialist Medical Devices

For our client, international leading company in the medical devices area we are looking for a Regulatory Affairs Specialist. This is assignment as a freelance consultant or as a project consultant for USG Professionals Science.

Functieomschrijving

  • You will be considered a key regulatory contact person enabling the regulatory compliance in the International Markets Area.
  • You are an impactful member of the Regulatory Affairs (RA) team and trusted by management as an independent regulatory team lead on multiple project teams.
  • You support multiple projects, will function on a multi-geography basis, are able to prioritize, conduct team meetings, and meet project deadlines.
  • Preparing regulatory strategies for new devices, new registrations and re-registrations/notifications due to product changes, regulatory changes, changes in Go2Market model.
  • Clearly communicates strategies to RA management and core teams.
  • Preparing and submitting product registration files to obtain or to keep marketing approval and import licenses per local Regulatory requirements for CE marked/FDA cleared devices in the countries of IGT-D’s distribution (EMEA,LATAM & APAC) in order to ensure that IGT-D’s products comply with the regulations
  • Able to professionally negotiate and lead meetings with internal and external customers (Marketing, R&D, Markets, Distributors). All significant issues are negotiated with the RA Manager.
  • Following Quality System procedures to ensure compliance with all other applicable regulations.
  • Maintaining proficiency in broad, regional regulatory requirements. Develop general strategies on more effective interactions with government agencies and agency personnel.
  • Assisting the RA Manager with training of more junior specialist staff.

Profiel

To succeed in this role, you should have the following skills and experience

 

• EU work authorization is a precondition of employment.

• BS degree in relevant field. (BS, MS, or PhD in Engineering or Science preferred.)

• 5+ years of medical device experience with BS degree and work experience in Regulatory Affairs, or 3+ years of medical device experience with MS degree and work experience in Regulatory Affairs, or 2+ years of Regulatory Affairs experience with PhD in Engineering/Science.

• Excellent communication both written and verbal as well as have experience with communication and presentations to senior leadership.

• Demonstrated experience in multiple types of International regulatory submissions (China, Korea, Saudi Arabia, Brazil, Russia, Australia, Colombia, Singapore, India, among others)

• Must have working knowledge of FDA, ISO, EU, and other applicable regional regulations for handling complaints, reporting incidents, and implementing corrective and preventative actions.

• Languages: English (written and spoken), knowledge of other languages is an asset

 

The candidate must have

 

1. Experience notifying placement of Medical devices on the Market EU Market (at least 2 years of experience)

2. Strong knowledge of the Medical Device Directive and Medical Device Regulations

3. Experience working with Distributors

4. Experience exporting Medical Devices internationally and supporting commercial activities (participation in tenders, handling procurement questions)

5. Experience legalizing documents to support import/export of Medical Devices worldwide

6. Proximity to the Zaventem Office to ensure a smooth support of document exchanged with a Notary in Zaventem

 

This is a temporary assignment, both freelance and project consultancy are an option. Contact me for more information: evie.dries@usgprofessionals.be

Aanbod

This is a temporary assignment, both freelance and project consultancy are an option. Contact me for more information: evie.dries@usgprofessionals.be
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    Nog 8 dagen om te solliciteren

    Kenmerken

    Vereisten

    • Professionele Bachelor (Hoger Onderwijs Korte Type)
    • Minstens 5 jaar ervaring
    • Engels

    Aanbod

    • Freelance
    • Onbepaalde duur
    • Bepaalde duur
    • Voltijds

    Solliciteer voor

    • 8 december

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