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

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

Description

Kenvue is currently recruiting for :

Senior Regulatory Affairs Specialist (Medical Devices) (f / m / d) (full time / part time optional)

The role is a 2 years fixed term contract and reports into the Senior Manager Regional Essential Health and is based at Neuss, Germany (hybrid).

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 - including 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 is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers.

With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage and have brilliant opportunities waiting for you! Join us in shaping our future and yours.

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 Self Care / Skin Health / Essential Health franchise.

• Evaluates and coordinates the regulatory deliverables for medical devices, within their geographical and / or brand area of responsibility
• 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 Self Care / Skin Health / Essential Health Franchise

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 applicable Processes, SOPs and working instructions
• Ensures 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

Monitors the regulatory environment (specific regulations, guidance and other relevant information by product types, geography, etc.

and maintains information resources.

Supports in trade association, working groups, developing impact assessments, influencing strategies, and leading solutions at EU and local level (if relevant).

Team Management

• Provides technical and leadership development as appropriate.
• Monitors progress of applications of self against set timelines, acting where necessary to minimize delays and anticipate difficulties.

Qualifications

Primary Location

Europe / Middle East / Africa-Germany-North Rhine Westphalia-Rhein-Kreis Neuss

Job Function

Regulatory Affairs