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 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

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

What We Are Looking For

Required Qualifications & Skills:

• Relevant Bachelor's Degree or higher
• Expertise on class I-III Medical Devices
• Knowledge of regulatory frameworks and external environments, and the ability to apply these to regulatory solutions throughout the product lifecycle
• Solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance
• Experience working with Notified Bodies
• Proficiency in English

Soft Skills:

Applied technical knowledge:

• Detailed knowledge of laws, regulations, and guidance as they apply to specific projects
• Ability to interpret them and understand them in the context of the scientific and commercial environment
• Demonstrates expansive thinking to assess and perform due diligence for business development opportunities

Business acumen:

• In-depth knowledge of the business, organizational goals, Regulatory Affairs function, and cross functional business partners to make informed business decisions and create and execute business strategies
• Ability to represent RA function on cross-functional teams and governance forums

External focus:

• Strong collaboration skills
• Ability to partner with the business to deliver regulatory outcomes to enable committed business plans within area of responsibility
• Ability to work with strategic direction to perform with independent judgment and execution which directly impacts the operational results of the business unit
• Experience in cultivating and leveraging strategic networks and partnerships

Leading and influencing:

• Strong interpersonal, organizational, and time management; applies organizational understanding and awareness in decision making

Persuasive communication:

• Effective communication, negotiation, conflict resolution, and influencing skills to grow key relationships with internal/external contacts are essential to the role

What's in it for you

• Competitive Benefit Package
• Paid Company Holidays, Paid Vacation, Volunteer Time & More!
• Learning & Development Opportunities
• Employee Resource Groups

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.