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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

What We Are Looking For

• 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

Core competencies:

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

• Opportunity to join the world’s largest pureplay organization with both local (Germany) and international developmental opportunities.

• Attractive remuneration package paired with access to additional benefits such as health insurance, employee recognition programmes, local resource groups, gym and canteen facilities on site.

• Hybrid working model including a “30 Days Working from anywhere” policy.

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 identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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

Job Function Regulatory Affairs

Req ID: 2407022944W