My client is a large Medical Device Business the North West that is now looking for a Senior Regulatory Affairs Specialist to join their team. The person will be responsible for the management of global and regional regulatory projects, including, but not exclusively, product life cycle and regulatory processes. There will be a focus on developing strategies and document preparation for products marketed in the US.
• Creation, development and maintenance of high quality regulatory compliant documentation, especially for Class II/Unclassified products for the US market.
• For medical device products under development liaise with Project Development teams to ensure regional RA requirements are included in the project plan and prepare the pre-marketing documentation e.g. for CE marking and 510k according to the agreed timeline
• Builds relationships and negotiates with relevant regulatory bodies on matters related to compliance of existing products and products undergoing development
• Creates new and innovative ways of doing things, demonstrates flexibility, open-mindedness, and adaptability to a rapidly changing environment.
• To assist with global regulatory processes, such as Change Control, GMDN, etc
• At least 5 year’s Regulatory/Quality experience in medical devices.
• Experience dealing directly with Notified Bodies, Competent Authorities, and US FDA
• Hands on experience of creating documentation compliant with FDA CFR 820 and EC Medical Devices Directive 93/42/EEC
• Knowledge of compliance with key international standards such as ISO 13485 and ISO 14971
• Demonstrate excellent communication skills
• Demonstrate strong organisational skills, including the ability to prioritise workload
• Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, manufacturing and commercial
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 178 7488. You can also e-mail us directly at Joseph@peoplewithchemistry.com to discuss in confidence.
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