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Senior Regulatory Affairs Specialist

vor 2 Monaten


Neuss, Nordrhein-Westfalen, Deutschland Kenvue Vollzeit
Senior Regulatory Affairs Specialist

Kenvue is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team in Neuss, Germany. As a key member of our Regulatory Affairs function, you will be responsible for developing and implementing regulatory strategies across the EMEA region and globally.

Key Responsibilities:
  • Evaluate and coordinate regulatory deliverables for medical devices, ensuring compliance with regional and global regulations.
  • Develop effective partnerships with R&D, Franchise, and local regulatory colleagues to drive regulatory strategies and technical guidance.
  • Assist in the preparation of technical files and submission packages for product certification and maintenance throughout their lifecycle.
  • Represent the Regulatory Affairs function within the Self Care/Skin Health/Essential Health Franchise.
Regulatory Strategy:
  • Work with local and regional regulatory colleagues to develop global and/or regional regulatory strategies, coordinating regulatory actions and results.
  • Provide regulatory advice and perform due diligence for product acquisitions and distributor agreements.
  • Organize materials from preclinical and clinical studies for review and assist in the review process.
  • Prepare and submit regulatory submissions according to applicable regulatory requirements and guidelines.
  • Assist in the scheduling of meetings with internal stakeholders and regulators, developing and organizing materials for these meetings.
  • Track the status of applications under regulatory review and provide updates to the regulatory team.
  • Familiarize and understand current regulatory legislation to keep legislative knowledge up to date at regional level.
Regulatory Compliance:
  • Maintain logs of communication and outcomes with regulators and other relevant internal or external stakeholders.
  • Maintain awareness of current regulations and anticipate implications and opportunities as a result of changes to the relevant regulatory environments.
  • Participate in the development and implementation of, and maintain compliance with, all applicable Processes, SOPs, and working instructions.
  • Ensure that the enterprise Regulatory systems are accurate and fully maintained.
  • Ensure any compliance issues are reviewed and escalated, and relevant corrective/preventative actions are implemented locally.
  • Identify and/or implement regional process improvement opportunities and ensure implementation of relevant global or regional regulatory initiatives.
  • Support internal and external audits and inspections in collaboration with quality function.
Regulatory Advocacy:
  • Monitor the regulatory environment and maintain information resources.
  • Support trade association, working groups, developing impact assessments, influencing strategies, and leading solutions at EU and local level (if relevant).

Requirements:

  • Primary Location: Europe/Middle East/Africa-Germany-North Rhine Westphalia-Rhein-Kreis Neuss
  • Job Function: Regulatory Affairs