Manager, Team Leader

Regulatory Affairs Manager ASPAC

bioMérieux

Marcy-l’Etoile, France

RESPONSIBILITIES

  • Management of RA-specialists and CA-specialists supporting the ASPAC-region (i.e. the local RA-teams and distributors), allocate appropriate resources to projects
  • In charge of regulatory watch (regulations, guidances) for reagents & instruments, with support from local RA; making sure that new or modified requirements are integrated in registration process (also in other functions at corporate level during development process)
  • Responsible for the registration and renewal of bMx products: obtain regulatory clearances and renewals as required (according to registration and renewal schedules)
  • Evaluate impact and registration/notification needs of changes to registered products and make sure that required information is communicated and available for submissions
  • Member of ASPAC –Leadership Team, represent RA-function, communicate on successes, challenges
  • Coordinate efforts with the LATAM/CAN and EMEA regional head as required to ensure that processes and procedures are consistent and efficient (continuous improvement)
  • Represent function during audits and inspections as required

REQUIREMENTS

  • Solid IVD/Medical Device Regulatory Affairs experience in Mainland China, experience in other Asian countries is a plus.
  • Previous Management experience
  • Chinese/English working proficiency (French is nice to have)
  • Open-minded, strategic thinking with good communication skills
  • Business partner to have a good balance between RA compliance and Commercial
  • Scientific background is preferable for clinical support

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

More Job Searches

France     Clinical Research     Manager and Executive     Medical Devices     Regulatory Affairs     bioMérieux    

© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies