Regulatory Operations Senior Associate Medical Devices Intimate Wellness

We are Reckitt

Research & Development

About the role

Regulatory and Safety Affairs (RAS) is a critical function within R&D-a key partner in developing the right portfolio strategy for breakthrough innovation, driving activation in our markets, and ensuring product security throughout the entire product lifecycle.

We actively engage with external stakeholders and regulators to anticipate and credibly influence changes in the regulatory environment. We bring that regulatory intelligence back to Reckitt to enable better-informed business decisions. Internally, we lead the thinking on what is possible, putting forward ideas that become reality. Acting as stewards of our brands and company, we deliver compliant and competitively positioned products to the people we serve.

As a Regulatory Operations Senior Associate, you will serve as the subject matter expert (SME) on requirements for this regulatory classification. You will be responsible for compiling, preparing, reviewing, and submitting regulatory documents to Notified Bodies and, where applicable, Health Authorities to support the launch of new innovations and the rollout of new and existing products.

In this role within Global Regulatory Operations and the RAS Team, you will execute the agreed regulatory strategy by delivering high-quality medical device dossiers and registration documentation. You will support regional and market registrations in collaboration with local regulatory teams.

You will ensure operational excellence in your area of responsibility and align priorities and resources with the Regulatory Operations Manager for Medical Devices. As part of the Regulatory Operations team, you will connect with RAS Strategy teams and project teams whenever input from your department is required.

You will be a critical partner to cross-functional colleagues across Regulatory Strategy and Operations, Consumer Safety, Risk Management/Vigilance, R&D, and Quality at Reckitt to ensure timely and compliant generation and review of data for medical device dossiers.

Finally, you will work in accordance with internal and external standards to ensure that all dossiers comply with regulatory requirements and internal quality benchmarks.

You will play an important role because.

We're proud of our organisation and continually strive to be the best that we can be. The Regulatory Operations Senior Associate plays an essential role to achieve and maintain compliance for new medical device products and existing portfolio.

Your responsibilities

• Responsible for the creation, delivery, and maintenance of medical device regulatory dossiers, driving consistency and direction, and applying your resources and expertise in line with the agreed regulatory strategy to achieve market registrations and launches according to planned timelines and ensure compliance with the existing pipeline.
• Managing a complex and diverse set of regulatory requirements and maintaining an overview of the regulatory landscape across multiple markets in close collaboration with regional and local teams. This includes identifying efficiency opportunities and adapting to local legislative changes to optimize data package delivery to markets, while communicating these requirements in business-friendly language to peers and cross-functional partners/stakeholders in a timely manner.
• Support and deliver training to business partners, providing materials that optimally prepare the business for the current and future regulatory environment.
• Work in partnership across RAS teams to develop, communicate, and implement the regulatory strategy in collaboration with cross-functional project teams, aligning on the content of regulatory submissions. Prepare and support the submission of registration dossiers while ensuring global activities are appropriately assessed for worldwide implications.
• Ensure collaboration with other cross-functional technical functions such as Safety, Quality, Medical, Marketing, Supply, Packaging, and R&D, as well as other RAS areas and local teams, to define requirements for submissions efficiently and in a timely manner.

You are also expected to:

• Be responsible for coordinating responses to questions received from regulatory authorities.
• Lead projects with a clear understanding of a broad set of registration and regulatory requirements across multiple markets, meeting project objectives and milestones.
• Be accountable for delivering project results in accordance with Reckitt's processes and procedures, and responsible for communicating risks and progress with appropriate guidance.
• Support wider operations teams to achieve targets and understand resource requirements. Help set clear priorities, review project progress, develop gap analyses, and implement resolutions.
• Maintain a strong understanding of internal business and regulatory processes.
• Author and review departmental SOPs and work practices.
• Seek opportunities to drive simplification and improvement.
• Support audits and audit readiness, both internal and external to Reckitt, with a good level of knowledge of regulatory guidelines and internal procedures.
• Proactively identify and promote relationships with regulatory partners and cross-functional stakeholders to support effective collaboration. Highlight the win-win nature of partnerships.
• Maintain oversight of your own resource needs and raise any issues in advance.
• Drive your own personal development with the support of your line manager, as well as support the development of individuals within the team.
• Ensure that projects are delivered as per plans and that appropriate and aligned prioritization is implemented.

The experience we're looking for

• At least 6 years of experience in regulatory affairs or R&D within industries such as pharmaceuticals, medical devices, biotechnology, or consumer health.
• Skilled in developing strategies and leading cross-functional teams through product development and regulatory submissions.
• You bring prior experience in European Medical Device Regulation (MDR) or a similar legislative area, with a strong track record of successfully delivered projects.
• You have knowledge and understanding of global product development and maintenance for Reckitt products, as well as current and emerging rules, regulations, and guidelines impacting medical device dossiers and regulatory file generation.
• You are educated to degree level in a scientific field or have equivalent experience.
• You build strong peer-to-peer partnerships and working relationships across RAS and all cross-functional teams in the organization, focusing on achieving common business goals.
• You have a keen eye for detail and the ability to consistently deliver on time, within cost, and to quality standards in a high-pressure environment, with a right-first-time approach.
• You demonstrate courage and empathy and work collaboratively across functions, embracing change with a growth and compliance mindset and inclusive leadership.
• You have a strategic mindset with the ability to anticipate future trends accurately, a broad perspective on regulatory implications and risks, and the capability to adapt these to regulatory operations activities.
• You can translate complex regulatory information into clear, compelling, and stakeholder-friendly language.
• You possess strong intellectual curiosity, an appetite for exploring new and uncharted territories, and an openness to change with the ability to think outside the box.

The skills for success

What we offer

Equality