Meet recruitment have partnered with a Global Medical Device Business that is now looking to fill a new role to help manage the ever-increasing Regulatory work load the industry is facing.
Within the Europe Middle East & Africa (EMEA) Regulatory Affairs organization, the main objectives of the role will be to contribute to successful regional business goals by supporting day to day regulatory activities in the Northern Europe region, in direct interaction with local regulatory authorities, with a focus on post-market surveillance activities.
• Interacts directly with regulatory authorities personnel and coordinate post-market surveillance activities, for all buisness units.
• In direct interaction with the business divisions, support the preparation, conduct and follow-up of regulatory authorities meetings on post-maket surveillance matters.
• Coordinate the preparation, review and submit timely responses to requests for additional information from regulatory authorities on vigilance and other post-market. surveillance matters in the region.
• Manage and execute regulatory-related activities associated with field safety corrective actions initiated in the region.
• Provides input and data on regulatory-related issues associated with compliance and achievement of the business plan in the region.
• Plan, execute and maintain product registrations with regulatory authorities for his/her respective product lines, in accordance with product launch plans, as applicable in the region.
• Support tender operations and business units by timely supply of acurate regulatory documentation and informaiton
• in collaboration with cross-functional project teams, plan, prepare and submit applications for clinical investigations to regulaotry authorities in the region, and coordinate responses to questions.
• Establish and maintain a good working relationship with regional regulatory afffairs, cross-functional peers and business units to gain positive & timely support.
• Serve as regulatory consultant to marketing and government teams as required.
• Experience of working in a Regulatory environment within the Medical Devices industry. Either Pre or Post Market experience is acceptable.
• Experience dealing with competent authorities.
• The ability to resolve Regulatory Conflict
• The ability to think on your feet and multi task.
Full job description and company details are available upon application, apply below. This position is being dealt with by Joseph Dykes at Meet, please call 0203 019 5972. You can also e-mail us directly at Joseph@peoplewithchemistry.com to discuss in confidence.
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Find out more about us at www.peoplewithchemistry.com