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Specialist II Germany Jobs

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Group Regulatory Affairs Specialist Class II
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Group Regulatory Affairs Specialist Class II needed in Großpostwitz, Germany. Ensure market access for medical devices by mastering US and Canada regulations, ISO 13485, and 510k submissions. Leverage 3+ years of RA experience to guide cross-functional teams and navigate SAMD requirements. Join O...
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Location
Germany , Grosspostwitz
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Salary
Not provided
ontex.com Logo
Ontex Peninsular
Expiration Date
Until further notice
Group Regulatory Affairs Specialist Class II
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Join Ontex as a Group Regulatory Affairs Specialist Class II in Grosspostwitz. You will ensure compliance for medical devices, focusing on US/Canada regulations and 510(k) submissions. This role requires a science master's, 3+ years of RA experience, and fluency in English. We offer attractive be...
Location Icon
Location
Germany , Grosspostwitz
Salary Icon
Salary
Not provided
ontex.com Logo
Ontex Peninsular
Expiration Date
Until further notice

About the Specialist II role

A Specialist II is a mid-level professional role that spans various industries, including retail, customer relations, regulatory affairs, and technical support. This position represents a significant step beyond entry-level, requiring a blend of advanced functional knowledge, coaching abilities, and cross-functional collaboration. Professionals in Specialist II jobs are typically tasked with not only executing complex tasks but also with elevating the performance of their teams through training, knowledge sharing, and process improvement.

In a customer-facing or sales environment, a Specialist II often serves as a subject matter expert for complex product areas or service resolutions. They are responsible for designing and delivering training programs, onboarding new team members, and coaching senior colleagues to enhance their skills. A core part of this role involves analyzing performance data, call recordings, and customer feedback to identify skill gaps and develop targeted learning materials. These specialists collaborate closely with leadership, learning and development teams, and knowledge management groups to ensure that all resources are accurate, engaging, and aligned with company standards. They also maintain direct customer interaction to keep their own expertise current, handling escalated issues across multiple channels such as phone, chat, and live video.

In regulatory or technical fields, a Specialist II focuses on compliance and product lifecycle management. They coordinate and compile submissions for regulatory approvals, such as 510(k)s, PMAs, and CE Markings, ensuring that all documentation meets local and international standards. This role requires reviewing product and manufacturing changes for regulatory impact, representing the regulatory affairs department on cross-functional product development teams, and providing clear guidance on labeling and technical reviews. The ability to work independently, communicate complex ideas simply, and manage multiple projects is essential.

Common responsibilities across all Specialist II jobs include: evaluating performance and suggesting improvements, creating and localizing educational content, collaborating with multiple stakeholders, and maintaining a high level of expertise in their specific area. The role demands strong analytical skills, proficiency with various software tools, and the ability to adapt training to different learning styles. Typical requirements for these positions include a bachelor’s degree in a relevant field (such as a scientific discipline for regulatory roles) and at least two to four years of related experience. Experience in coaching or training senior colleagues is often valued, along with fluency in multiple languages for global roles. Ultimately, Specialist II jobs are ideal for experienced professionals who enjoy combining hands-on expertise with mentoring and strategic process improvement to drive team and organizational success.