Senior Regulatory Affairs Specialist
vor 12 Stunden
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 relevant regulations and guidelines.
- Develop effective partnerships with R&D, Franchise, and local regulatory colleagues to drive regulatory strategy 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.
- 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.
- 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.
- 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
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