Senior Regulatory Affairs Specialist (Medical Devices) (f/m/d) - Fixed-Term for 2 Years

Description

Kenvue is currently recruiting for:

Senior Regulatory Affairs Specialist (Medical Devices) (f/m/d) - Fixed-Term for 2 Years

The role reports into the Senior Manager Regional Essential Health and is based at Neuss, Germany (hybrid).

Who We Are

At Kenvue we believe there is extraordinary power in everyday care.

Built on over a century of heritage and propelled forward by science, our iconic brands-including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® and BAND-AID® -are category leaders trusted by millions of consumers who use our products to improve their daily lives.

Our employees share a digital-first mindset, an approach to innovation grounded in deep human insights, and a commitment to continually earning a place for our products in consumers' hearts and homes.

What You Will Do

The Senior Regulatory Affairs Specialist is responsible for the development of regulatory strategies across the EMEA region, and globally as relevant, providing regulatory input and technical guidance on regulatory requirements to product development teams within the Essential Health franchise.


* Evaluates and coordinates the regulatory deliverables for medical device


* Develops effective partnerships with R&D, Franchise (Marketing) and local regulatory colleagues


* Assists in the preparation of technical files and submission packages for the certification and maintenance of products throughout their whole lifecycle


* Represents the Regulatory Affairs function as appropriate within the Essential Health Franchise

Key Responsibilities

Regulatory Strategy


* Works with local and regional regulatory colleagues to develop global and/or regional regulatory


* strategies, coordinating regulatory actions and results and develops global/regional dossiers to support local review processes


* Provide regulatory advice and perform due diligence for product acquisitions and distributor


* agreements with third parties


* Organizes materials from preclinical and clinical studies for review and assists in the review process


* Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines


* Assists in the scheduling of meetings with internal stakeholders and regulators and develops and organizes materials for these meetings


* Tracks the status of applications under regulatory review and provides updates to the regulatory team


* Familiarizes and understands the current regulatory legislation to keep the legislative knowledge up to date at regional level

Regulatory Compliance


* Maintains 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 ap...