Logo of Huzzle

Regulatory Affairs Specialist Medical (d/f/m)

image

Essity

2mo ago

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

AI generated summary

  • You should have 2+ years in a regulated environment (medical devices/pharma), IT skills, attention to detail, collaborative ability, and fluency in German or English.
  • You will manage document control in a regulated environment, oversee approvals, ensure compliance across departments, maintain SAP classifications, and provide user support globally.

Requirements

  • 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
  • Excellent German or English language skills

Responsibilities

  • Initiate and drive process improvement activities for local document control activities within a regulated environment (e.g. Medical Device Regulation 2017/745/EU)
  • Maintain document control activities and steer document circulating
  • Formal check and approval of documents and templates
  • Ensure that the activities of other departments involved in releasing/changing controlled documents adhere to document control prerequisites
  • Maintain classifications in SAP and apply/change SAP attributes
  • SAP User Management and First Level problem support for medical SAP User globally

FAQs

What is the main focus of the Regulatory Affairs Specialist Medical position at Essity?

The main focus is to support the Regulatory Affairs department by initiating and driving process improvement activities related to document control in a regulated environment, particularly in accordance with Medical Device Regulation 2017/745/EU.

What qualifications are required for this position?

A candidate should have at least two years of expertise in a highly regulated environment, preferably in medical devices or pharmaceuticals, as well as experience with Microsoft Office applications, SAP, and document control.

Is prior experience in medical devices necessary for this role?

While it is preferable, candidates with experience in other highly regulated environments may also be considered.

What are the language requirements for this position?

Excellent proficiency in either German or English is required.

What type of working environment does Essity offer?

Essity offers a hybrid working model with flexible working hours.

How many vacation days do employees receive?

Employees receive 30 days of vacation annually.

Are there training and development opportunities available?

Yes, Essity provides structured onboarding, digital learning platforms, coaching, mentoring, and participation in professional conferences and fairs.

What health and wellness benefits does Essity offer?

Benefits include discounted fitness memberships, health and well-being months, mindfulness courses, and access to surveys for employee wellness.

How does Essity foster an inclusive workplace?

Essity actively promotes diversity, equity, and inclusion, and is committed against discrimination based on various factors, explicitly welcoming applications from individuals facing structural and institutional discrimination.

Who can I contact for more information about the role?

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

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.