Senior Regulatory Affairs Specialist (d/f/m)

Overview
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 an senior expert in the to support our team as soon as possible.

This position is limited to 2 years.

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 tarif, 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 conferencesand 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.

We are committed against discrimination on the basis of color, ethnicity, migration history, religion, sex, national origin, sexual orientation, age, citizenship status, marital status, caregiving responsibilities, disability, chronic illness, gender identity, gender expression, genetic information and other. We explicitly welcome applications from people who are structurally, institutionally, intersectionally discriminated.

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