Market leading Global Class II Medical Device company is now looking to hire a Regulatory Manager for their team based in the Germany. This role would put you in Leadership role that is pivotal to the business and will up skill someone who is looking to take hold of a process from end to end, as well as being perfect for someone who is looking to step up in to management. General responsibilities include;
• Provide independent regulatory guidance to business partners and cross function project teams including communicating details on the regulatory landscape and product submission requirements.
• Represent the company as its European Authorized Representative.
• The role is a key role within the business, interfacing with customers and other company departments on a regular basis.
• Due to the nature of the business the individual must be able to demonstrate the ability to deliver to critical deadlines and manage their workload and time effectively.
• Travel is required to fulfil the expectations of the role and support the regulatory affairs activities for Advanced Medical Solutions sites.
• Contact person for new product development (NPD) and the existing product portfolio
• Compile and maintain Regulatory Files e.g. Technical Files, Design Dossiers, PMA and 510(k) files.
• Provide regulatory input to new product developments and major extensions to existing product lines.
• Maintain current registrations, licenses, Regulatory Certification, and submissions to ensure compliance with the latest Medical Devices regulations.
• Supporting and advising other functions within the business for information requests, review of labelling, publications, and marketing material
• Support internal and external audits including health authority audits such as Notified Bodies, competent authorities, US FDA, etc.
• To promote health and safety policies in the workplace.
• A minimum of a Bachelor’s Degree is required. An advanced degree (Masters, PhD, PharmD, etc.) is preferred
• A minimum of 5 years direct Regulatory Affairs.
• Demonstrated experience with compiling and submitting EU regulatory submissions (Class IIa, IIb, and III CE submissions) is essential and US (FDA) would be preferred.
• Experience with combination products and/or products of animal origin preferred.
• Working knowledge of European devices requirements and regulations is required.
• Strong communication and technical writing skills required.
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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