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Sr. Regulatory Affairs Manager

2019-05-21 Forexx Group B.V. | Eindhoven | WO / MBA | Vast dienstverband | Sluit 2019-07-20

In this position the Sr. Manager will responsible for leading High Profile Medical Device development projects for the Beauty business who is part of Personal Care.

Senior Regulatory Affairs Manager

The Senior Regulatory Manager is part of the Regulatory Affairs Team of the Innovation Site Eindhoven (ISE). In this position the Sr. Manager will responsible for leading High Profile Medical Device development projects for the Beauty business who is part of Personal Care. The Sr. Regulatory manager is a strategic partner for the business groups. The activities will focus on the hair removal devices.

Senior Manager with strong commercial business sense, who has consumer safety and product compliance top of mind. Able to work in a high pressure, result driven, project environment. Strong communicator and collaborator and team player. Excellent English language skills in writing and speech. HBO or University level of thinking.

Activties include;

  • Take “Regulatory Ownership” of the Medical Devices, being the primary point of contact for the development teams.
  • Involved early in Advanced Development Projects and Value Proposition Creation
  • Involved in Clinical Claim Development
  • Create Assessments of Medical Device Classifications for applicable Markets globally
  • Create Regulatory Strategy Plan for new Hair Reduction device projects
  • Review Product Compliance Plans as created by Safety & Compliance Managers
  • Create Product Labeling Plan
  • Review Clinical Study Plan and Reports
  • Create Regulatory Medical Device Submission Packages for markets like EU, U.S., Brazil, China.

Must have items

  • 10-15 year experience in medical device regulations, in a commercial environment
  • Global medical device regulation knowledge for EU (MDD and EU-MDR), United States (FDA), Brazil (Anvisa)….
  • Proven successful track record in regulatory submissions for medical devices
  • Knowledge of Clinical Study setup, execution and reporting..
  • Familiar with MDSAP and ISO 13485
  • Knowledgeable on Product Risk Assessment strategies
    • Strong Senior Personality being able to take position and guide a project team

nice to have items

  • Knowledge of different standards for household and medical devices (e.g. electrical standards)
  • Knowledge on Software Development
  • Pharmaceutical background

Start date
Asap

Duration
At least 1 year, but realistically more project might be longer. Right of employment after 12 months should be part of the options



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