Regulatory Affairs jobs in Allemagne

Senior Regulatory Affairs Specialist (Medical Devices) (f / m / d) (full time / part time optional) - fixed-term-contract-2407022944W

Kenvue is currently recruiting for a Senior Regulatory Affairs Specialist (Medical Devices) (f / m / d) (full time / part time optional).

The role is a 2-year fixed-term contract reporting to the Senior Manager Regional Essential Health, based in Neuss, Germany (hybrid work model).

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands—NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSON’S, and BAND-AID—that you already know and love. Science is our passion; care is our talent. Our global team of 22,000 diverse and brilliant people is passionate about insights, innovation, and committed to delivering the best products to our customers. Being a Kenvuer means having the power to impact the lives of millions daily. We put people first, care fiercely, earn trust with science, and solve with courage. Join us in shaping our future—and yours.

The Senior Regulatory Affairs Specialist is responsible for developing regulatory strategies across the EMEA region and globally, providing regulatory input and technical guidance to product development teams within the Self Care / Skin Health / Essential Health franchise.

1. Evaluate and coordinate regulatory deliverables for medical devices within their geographical and brand responsibilities.
2. Develop effective partnerships with R&D, Marketing, and local regulatory colleagues.
3. Assist in preparing technical files and submission packages for product certification and lifecycle maintenance.
4. Represent Regulatory Affairs within the franchise.

1. Collaborate with local and regional colleagues to develop global/regional regulatory strategies.
2. Coordinate regulatory actions and develop dossiers to support local review processes.
3. Provide regulatory advice and perform due diligence for product acquisitions and distributor agreements.
4. Organize materials from preclinical and clinical studies for review.
5. Prepare and submit regulatory submissions according to applicable requirements.
6. Schedule and prepare materials for meetings with stakeholders and regulators.
7. Track application statuses and update the regulatory team.
8. Stay informed about current regulatory legislation at regional levels.

1. Maintain logs of communications with regulators and stakeholders.
2. Stay updated on regulations and anticipate implications of legislative changes.
3. Participate in developing and maintaining compliance with processes, SOPs, and instructions.
4. Ensure regulatory systems are accurate and maintained.
5. Review and escalate compliance issues, implementing corrective actions.
6. Identify and implement process improvements and support audits and inspections.

1. Monitor the regulatory environment and maintain information resources.
2. Support trade associations, working groups, impact assessments, and influence strategies at EU and local levels.

1. Provide technical and leadership development.
2. Monitor application progress, minimize delays, and anticipate difficulties.

Details not specified in the provided description.