Reckitt
Regulatory Operations Specialist - Medical Devices
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We are Reckitt
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 Research and Development, 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 Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.
About the role
The Regulatory Operations Specialist plays an essential role to achieve and maintain compliance and business continuity for our existing portfolio of medical devices across the whole product lifecycle, whilst also ensuring we are an effective, well-connected organisation.
Your responsibilities
- Supporting post launch regulatory activities for all planned and unplanned compliance and maintenance activities for our medical device portfolio across all markets
- Ensuring regulatory changes are implemented within our registration files on a global basis working on collaboration with regional RAS teams, RAS strategy teams and global cross functional partners (which include R&D, procurement, sustainability, supply, quality and any other department where regulatory support is required) with a right first time approach.
- Ensuring both planned and unplanned maintenance activities e.g. renewals are completed in a timely manner to ensure business continuity
- Driving efficiencies and operational excellence within RAS, align on priorities and resourcing with the Regulatory Operations Team.
- Ensuring that you work according to internal and external standards, to ensure our products are compliant according to regulations and internal standards
- Managing a complex and diverse set of regulatory requirements and landscape overview across multiple markets
- Ensuring regulatory information on various systems and databases are kept up to date
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The experience we're looking for
- Prior experience in Medical Devices or an equivalent regulatory classification is preferred
- An ability to work on multiple projects at any given time and a capability to work with the line manager to prioritise and manage workload
- You have the knowledge and understanding of regulatory requirements associated with Reckitt products. Medical Device experience is a benefit but not a requirement
- You have high scientific credentials with a Bachelor of Science (BSc) / Master of Science (MS) degree in a relevant scientific discipline – such as Chemistry, Biological Sciences, Microbiology, Pharmacy, or significant applied industry experience
- You have an ability to deliver to time, cost and quality standards in a fast paced, high-pressure environment
- You have a strong collaborative mindset and able to form strong partnerships with cross functional teams
- You have a basic understanding how to translate complex regulatory information into a compelling stakeholder friendly language.
- You strive for a high level of accuracy in authoring documentation, with a focus on ensuring the level of registered information is appropriate in the dossiers
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The skills for success
- Task Execution Under Pressure
- Business Acumen
- Commercial Awareness
- Objective Setting
- Accountability
- Consumer Insight
- R&D
- Product Lifecycle Management
- Intellectual Property
- Business Partnership
- Collaboration and partnership building
- Adapt to changes in technological development plans
- Ability to challenge the status quo and propose improvement
- Innovation Processes
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 in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitt's potential future successes. For eligible roles, we also offer short-term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt's pay for performance philosophy.
Equality
We recognise that in real life, great people don't always 'tick all the boxes'. That's why we hire for potential as well as experience. Even if you don't meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you.
All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.
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