Mantell Associates are thrilled to have partnered with one of the most technologically advanced, game changing Medical Device companies who have completely transformed the world of imaging. Due to significant growth in every division they are looking for a Director of Global Regulatory Affairs to join their highly successful and scaling Quality & Reg team.
Director of Global Regulatory Affairs - Responsibilities:
Work strategically across divisions and stakeholders to understand key regulatory objectives, ensuring alignment with business growth objectives.
Prepare regulatory plans across current global operational regions as well as potential areas of market growth
Execute regulatory reviews of CAPAs.
Work with internal and external stakeholders to ensure that regulatory plans and timelines are well defined
Be responsible for conducting regulatory reviews, reporting and any necessary complaint handling
Director of Global Regulatory Affairs - Requirements:
Bsc / Msc in a Medical Devices, Biotechnology or related Life Sciences specialism
Experience working in Regulatory Affairs within Medical Devices is essential
Significant experience writing and leading global regulatory medical device submissions
Experience working with invasive Medical Devices is highly desirable although not essential
Have you worked with EU products and regulations
This role will be mostly onsite, based just outside Cambridge MA. Please ensure you are able to commute / relocate to the location before applying. Sponsorship is a possibility for this company.
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, please contact us at +44 (0)20 3854 7700.