Regulatory Affairs Specialist - Medical (d/f/m) at Essity
Hamburg, Hamburg, Germany -
Full Time


Start Date

Immediate

Expiry Date

15 May, 25

Salary

0.0

Posted On

15 Feb, 25

Experience

3 year(s) or above

Remote Job

No

Telecommute

No

Sponsor Visa

No

Skills

Regulatory Affairs, Medical Devices

Industry

Pharmaceuticals

Description

REGULATORY AFFAIRS SPECIALIST - MEDICAL (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.
We are looking for an expert to join the registration team at BSN Medical GmbH. In this role, you will oversee global medical device submissions and collaborate with both local and international stakeholders to ensure compliance with all relevant regulations.

Responsibilities
  • Develop and Implement Submission Strategies : Develop and implement submission strategies for the assigned product assortment of BSN Medical GmbH in alignment with relevant stakeholders in non-EU markets
  • Update Product Licenses and Processes : Keep product licenses and supporting processes updated with changes during product lifecycle management and changes in relevant regulations
  • Utilize Legal Knowledge : Utilize knowledge of national and international laws, regulations, guidance documents, and standards to shape and continuously improve regulatory documentation and registration activities
  • Ensure Regulatory Adherence : Ensure regulatory adherence in non-project-driven business processes such as marketing and sales, quality management, sourcing, and supply for global markets
  • Contribute to Regulatory Strategy : Contribute to the creation, implementation, and development of the regulatory strategy for global markets
  • Coordinate Communication : Coordinate communication necessary for product registrations with internal and external stakeholders, particularly regulatory authorities
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