Regulatory Affairs Director (Medical Devices, FDA, Electromechanical, Pumps)

Posted 14 February by We Are SSG
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Regulatory Affairs Director (Medical Devices, FDA, Electromechanical, Pumps)

Netherlands

To €175k plus benefits

Innovative medical device company based in The Netherlands, focused on the research and development, manufacturing and commercialisation of a ground breaking device for health management, with the smallest and lightest system currently available, designed to help peoplelive life on their own terms.

This a dynamic fast-growing company with a great product, stimulating and flexible working environment, international workforce of 83 people from 24 different nationalities with English as the common language.

The company is poised to enter the global market, the product is CE marked and currently available throughout the Netherlands and is preparing for FDA approval and expansion into additional territories in 2019.

  • The smallest and lightest system available
  • Unique mechanism delivering superior accuracy
  • Proprietary and IP protected
  • Low manufacturing cost of disposable cartridge
  • Platform for connectivity

Reporting directly to the CEO the Regulatory Affairs Director will be responsible for leading the regulation process for all Company medical devices, from the development of regulatory strategies, preparing and filing the necessary applications and handling all governmental/ regulatory agency interactions through to approval. Part of the Senior Leadership Team with 2 direct reports.

EXPERIENCE

  • 10 years + proven track record in Regulatory Affairs, preparing submissions for Class II medical devices in the US, EU and internationally for successful approval.
  • A Bachelor’s degree in Engineering, Life Science or equivalent.
  • Able to work independently and multitask in a timeline driven late stage start-up/ early commercial environment.
  • Solid knowledge of US and European regulatory processes.
  • Extensive experience in the preparation, and submission of Pre-IDEs, IDEs, PMA supplements, Technical Files, Dossiers and amendments and a successful track record.
  • Excellent verbal and written communication, presentation skills, including experience presenting at FDA meetings.
  • Able to communicate clearly, succinctly and effectively over the phone and in writing with various stakeholders including Regulatory Agencies.
  • Skilled in leading and mentoring staff through influence rather than position power to achieve significant results
  • Have strong professional ethics and integrity, sound judgment and the ability to take decisive action
  • Be credible with exceptional relationship-building and interpersonal skills
  • Strong verbal and written communication skills in English. Dutch language is not required
  • Solution focussed with a high level of self-motivation, drive and tenacity
  • Work requires willingness to work a flexible schedule.


Reference: 37284003

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