Regulatory Operations Associate - Medical Devices First Launch

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​

Regulatory and Safety Affairs is a critical function within R&D: a key partner in developing the right portfolio strategy for brilliant innovation, activation in our markets and secure the products during all product life cycle.

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.

About the role

Regulatory Operations Associate - Medical Devices First Launch 

Kingston Upon Hull, Hybrid Working

Competitive Salary & Excellent Benefits Package, 25 Days Annual Leave, Bonus, Private Healthcare, Pension Contribution

Closing date: 8th May 2024

You will form part of the wider Regulatory Operations Classifications Team and will be liaising RAS Strategy teams and project teams where input from your department is required. This position will form part of the wider Regulatory Operations Classifications Team and will be liaising RAS Strategy teams and project teams where input from your department is required. You will directly supporting the Local Hero portfolios with brands such as Optrex, Bonjela and Steradent. You will also have exposure to our further medical device portfolios including Intimate Wellness (Durex) that sit within the new launch team.

Your responsibilities

• Responsible for the operations input into the development of innovative global regulatory strategies to support global product initiatives.
• Managing a complex and diverse set of regulatory requirements and landscape overview across multiple markets to enable dossier maintenance and compliance post launch. 
• Work collaboratively within the RAS strategy, local market and intelligence teams, Medical, R&D and commercial cross-functional community to define global dossier requirements and documentation and deliver high quality data packages. Highlights of any potential issues, working with the authoring functions and LRA.
• Responsible for delivery of submissions to agreed operations time frames and collaborate across partner functions to ensure timely delivery of all information required.
• Ensuring through dynamic resourcing with the Regulatory Operations Manager that sections of the dossiers are delivered as per plans and that appropriate and aligned prioritization is implemented. This includes any relevant variations linked with supply and compliance plans for example.
• As expert in regulatory dossier management and registration activities, you will be up to date on external regulatory requirements.

The experience we're looking for

- Degree in a scientific field with a robust understanding of global regulatory environments impacting consumer products.

- Experience in dossier creation, submission, and product lifecycle management.
- A track record of reviewing and authoring high-quality documents.
- Ability to deliver consistently under pressure, adhering to cost, time, and quality standards.
- Familiarity with the regulatory requirements for medical devices in the EU (MDR)
- Commercially aware, adept at building partnerships and proposing improvements to enhance business processes.
- Capable of embracing change and setting clear objectives in line with our business goals.

The skills for success

Commercial Awareness, Business Partnership, Collaboration, Partnership building, Regulatory, Dossier writing, Collaborator, Product Lifecycle Management, Ability to challenge the status quo, Propose improvement, Accountability, Adaptability, Objective Setting, Business Strategy. Medical Devices. MDR regulations. NPD.

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.