Senior Regulatory Affairs Specialist (d/f/m)

Essity
Hamburg
EUR 80.000 - 100.000
Jobbeschreibung

Senior Regulatory Affairs Specialist (d/f/m)

Essity is a leading global hygiene and healthcare company. We are committed to improving the quality of life through high-quality hygiene and healthcare solutions. We sell our products and solutions in around 150 countries under many strong brands, including the global market leaders TENA and Tork, as well as well-known brands such as Jobst, Leukoplast, Libero, Libresse, Lotus, Nosotras, Saba, Tempo, Vinda, and Zewa.

For our Regulatory Affairs department, we are looking for a senior expert to support our team as soon as possible.

Your Role

  • Initiate and drive process improvement activities for medical device related local document control activities within a regulated environment (e.g. Medical Device Regulation 2017/745/EU).

  • Formal check and approval of documents and templates.

  • Ensure the activities of other departments involved in releasing/changing controlled documents adhere to document control prerequisites.

  • Maintain UDI activities for implementation, e.g. responsible for defining UDI attributes in the documentation management system (SAP).

  • Maintain classifications in SAP and apply/change SAP attributes, SAP user management and first level problem support for medical SAP user.

  • Prepare and conduct SAP trainings.

You Identify Yourself With

Even if not all of the following points apply to you, we would be happy to get to know you and talk about the possibility of working with you!

  • Associate or Bachelor degree, preferable in documentation.

  • At least two years expertise in a highly regulated environment, preferable medical devices or pharma.

  • IT skills like experience with Microsoft Office applications, SAP and document control.

  • Interest in routine tasks - thorough, analytical and structured working attitude.

  • Proven ability to effectively work collaboratively in cross functional teams.

  • Ability to advise/train others with a positive mindset about document control topics.

  • Excellent German or English language skills.

Our Benefits for You

The benefits listed refer to the primary location. If you want to start at another location, these may vary.

  • Compensation & Benefits
    Compensation according to the chemical tariff, yearly special payment, holiday allowance and bonus, pension schemes, anniversary bonus, child allowance, Corporate Benefits & other employee benefits.

  • Work-Life-Balance
    Hybrid working model, flexible working hours, overtime compensation, 37.5h week, 30 days of vacation, future amount (can be used as 5 days of vacation, Lease-a-bike or payout), lifetime working time account.

  • Learning & Development
    Structured onboarding, training opportunities such as digital learning platform, coaching & mentoring as possible part of individual development plan, participation in professional conferences and fairs.

  • Health & Well-being
    Discounted fitness membership, health and well-being month, Walk-and-Talk Meetings, nilo.health & mindfulness courses, "PME Familienservice", employee surveys.

  • Team & Collaboration
    People culture, communities & networks, co-working spaces, leadership guidelines, canteen.

  • Mobility
    Public transport allowance, bicycle parking, free car parking, e-charging stations.

This is Us

At Essity, our Beliefs & Behaviours (Care, Collaboration, Courage and Commitment) is the foundation for our inclusive culture and as such something we are living on an everyday basis. With a purpose of Breaking Barriers to Well-being, diversity, equity & inclusion is established in our core.

Let’s Connect!

Lina from the Talent Acquisition Team is happy to answer any questions related to the open role.

Application End Date:

Job Requisition ID:

Essity247698

About Us

Essity - a globally leading hygiene and health company, breaking barriers to well-being. Our expertise in hygiene and health began with the acquisition of the Swedish company Mölnlycke in 1975, through which our roots stretch back to 1849. Today, our sustainable innovations from globally trusted brands, designed for everybody and every body, care for the well-being of 1 billion people in 150 countries every day.

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