Regulatory Operations Associate Medical Devices

4 months ago

Kingston upon Hull, United Kingdom Reckitt Full time

Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose.

Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.

**Research & Development**:
In R&D, we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance.

We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.

The size of our organisation means you'll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our R&D Academy, designed to develop our team and allow you to grow in our great organisation.

**About the role**:
Regulatory Affairs is a critical function within Reckitt: a key partner in developing the right portfolio strategy for brilliant innovation and activation in our markets.

We actively engage externally with stakeholders and regulators to anticipate and credibly influence changes to the regulatory environment, and we bring that regulatory intelligence back to Reckitt to drive better informed business decisions. We lead the thinking internally about what is possible and put forward ideas that become reality, acting as stewards of our brands and our company to deliver compliant and competitively positioned products to the people we serve.

Working with the Senior Associate, you will ensure the development of regulatory strategies to drive regulatory expertise and understanding for post launch activities throughout the project.

You will collaborate with Local Regulatory to define registration requirements and timings of projects and critical regulatory parameters in data and timings. Key stakeholder for this role include Supply, R&D, Medical, GVG, Safety and many more.

**Your responsibilities**:

- Enable delivery of compliance activities to global markets by providing key skills and expertise in dossier creation
- Support an integrated approach to regulatory planning across innovation and will provide medical device knowledge and the latest information on dossier/technical file requirements.
- Ensure that all regulatory activities are completed according to the best process, in a consistent approach across projects.
- Wide stakeholder management including R&D, Medical, Local Reg, Supply and Safety
- Work in partnership with the local regulatory teams to identify and be aware of key requirements and that they are taken into account to deliver a ‘right first time’ approach for existing products on the market.
- Responsible for delivery of dossier/technical file to agreed time frames and collaborate across partner functions to ensure timely deliver of all information required, to enable robust and consistent project updates.
- Ensure high quality and accuracy of the dossiers vs the agreed requirements and highlighting of any potential issues, working with the authoring functions and LRA.

**The experience we're looking for**:

- Educated to honours degree level in a scientific field, Life Sciences being preferred
- Regulatory Experience and knowledge in dossier/technical file creation and global registrations.
- Knowledge of the Regional and Global regulatory environment and how it impacts regulatory dossiers and registration
- Experience in preparing and submitting dossiers, variations, and renewals.
- Ability to communicate requirements to the cross functional team
- Understanding of global product development practice, rules, regulations, and guidelines.
- Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines relevant to dossier deliveries.
- High level of accuracy in reviewing and authoring documentation
- Ideally have a knowledge of medical devices and the MDR in the EU and knowledge of how to navigate and search for changes in the regulatory landscape
- Good understanding of the FMCG industry

**The skills for success**:
Regulatory, Dossier Writing, Collaborator, Adaptability, Communication, Life Science, FMCG Background, Medical Device

**What we offer**:
With inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way.

We invest i

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