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Senior Regulatory Affairs Specialist (d/f/m)

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Essity

2mo ago

  • Job
    Full-time
    Junior Level
  • Hamburg
  • Quick Apply

AI generated summary

  • You need an Associate/Bachelor's degree, 2+ years in a regulated environment, IT skills, strong teamwork, training ability, and excellent German or English proficiency.
  • You will drive process improvements, formalize document checks, ensure compliance, manage UDI activities in SAP, maintain classifications, and conduct SAP training sessions.

Requirements

  • 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

Responsibilities

  • 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

FAQs

What is the role of a Senior Regulatory Affairs Specialist at Essity?

The Senior Regulatory Affairs Specialist is responsible for driving process improvements in medical device-related documentation, ensuring adherence to document control prerequisites, maintaining Unique Device Identification (UDI) activities, and conducting SAP training, among other responsibilities.

What qualifications are required for this position?

Candidates should ideally have an Associate or Bachelor degree, preferably in documentation, along with at least two years of expertise in a highly regulated environment, such as medical devices or pharmaceuticals.

What kind of work environment does Essity provide?

Essity offers a supportive work environment with flexible working hours, a hybrid working model, and a focus on work-life balance, including 30 days of vacation and overtime compensation.

Are there opportunities for professional development?

Yes, Essity offers structured onboarding, training opportunities, coaching and mentoring, and participation in professional conferences and fairs as part of individual development plans.

What languages are required for this position?

Excellent German or English language skills are required for the role.

How does Essity promote diversity and inclusion in the workplace?

Essity is committed to diversity, equity, and inclusion and explicitly welcomes applications from individuals who are structurally, institutionally, or intersectionally discriminated against, ensuring a fair and inclusive hiring process.

What benefits does Essity offer employees?

Benefits include compensation according to the chemical tariff, health and well-being programs, mobility options like public transport allowance, learning and development opportunities, and a supportive team culture.

Who can I contact for more information about this job?

You can reach out to Lina from the Talent Acquisition Team for any questions related to the open role.

When is the application deadline for this position?

The application end date for this position is not specified in the job description. Applicants are encouraged to apply as soon as possible.

What is the Job Requisition ID for this position?

The Job Requisition ID for this position is Essity247698.

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Essity

A global, leading hygiene and health company #BreakingBarriersToWellbeing

Manufacturing & Electronics
Industry
10,001+
Employees
2017
Founded Year

Mission & Purpose

Essity is a global hygiene and health company that focuses on developing, producing, and selling personal care and hygiene products. Their portfolio includes items such as baby diapers, feminine care products, incontinence products, and medical solutions. The ultimate mission of Essity is to improve well-being by offering sustainable and innovative hygiene and health solutions. Their purpose revolves around promoting health and hygiene practices globally while minimising their environmental impact. Essity aims to contribute to society's well-being by providing products that enhance people's quality of life, ensuring responsible production and consumption, and driving positive change in the areas of health, hygiene, and sustainability.