Senior Regulatory Affairs Specialist (Medical Devices) (f / m / d) (full time / part time optio[...]

Kenvue; Neuss; Hybrid; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

Join a forward-thinking company as a Senior Regulatory Affairs Specialist, where you will play a vital role in shaping regulatory strategies for medical devices across the EMEA region. This engaging position offers the opportunity to collaborate with diverse teams, ensuring compliance and driving innovation in product development. With a focus on delivering exceptional care, you will help navigate the regulatory landscape, influence strategies, and support product certification processes. If you're passionate about making a difference and thrive in a dynamic environment, this role is perfect for you.

Qualifikationen

• Experience in regulatory affairs for medical devices.
• Strong understanding of EMEA regulatory requirements.

Aufgaben

• Develop regulatory strategies for medical devices across EMEA.
• Coordinate regulatory actions and develop dossiers for submissions.

Kenntnisse

Regulatory Strategy Development

Technical File Preparation

Regulatory Compliance

Stakeholder Communication

Ausbildung

Bachelor's Degree in Life Sciences

Master's Degree in Regulatory Affairs

Tools

Regulatory Submission Software

Project Management Tools

Jobbeschreibung

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

Description

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).

Who We Are

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.

What You Will Do

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.

Regulatory Strategy

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.

Regulatory Compliance

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.

Regulatory Advocacy

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.

Team Management

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

Qualifications

Details not specified in the provided description.