Johnson & Johnson is currently seeking a Regulatory Affairs Associate to join our team located in Blackpool. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential. At Johnson & Johnson, we all belong. Role Purpose The Regulatory Affairs Associate will execute regulatory activities to support currently marketed devices and new product development in the Johnson & Johnson Orthopaedics Joint Reconstruction and Cement line of products. This role involves a multi-faceted set of skills including sound regulatory judgment, cross-functional collaboration, and planning/oversight/execution of projects & activities that directly impact the operational results of the business. What you will be doing: Under the guidance of Regulatory Affairs management: Provide regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches. Execute the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers. Guide conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials. Define data and information needed for regulatory approvals. Assist in the development of labeling specifications and approve proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations. Provide Regulatory Affairs support during internal and external audits. Plan schedules for regulatory deliverables on a project and monitor project through completion. Assist in the development of best practices for Regulatory Affairs processes. Represent Regulatory Affairs on cross-functional project teams. Partner with other functions to define and obtain data to assist with regulatory submissions. Communicate business related issues or opportunities to next management level. Follow all Company guidelines related to Health, Safety and Environmental practices as applicable. Ensure personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. Perform other duties assigned as needed. Qualifications What you will bring: BSc or equivalent working experience. Practical experience with the preparation / support of submissions for Class I, II and III medical devices (EU and USA). Experience of EU and International Regulations required. Knowledge of International Regulations preferred. Onsite RA expertise to Blackpool. Other skills/experience you might have: Excellent written, verbal communication and presentation skills. Leverage scientific and technical understanding of regulated products to provide strategic guidance and support for product development and life-cycle management of products. Integrate and execute results-oriented Regulatory Affairs strategies aligned with organizational objectives. Tactical and strategic regulatory knowledge necessary to gain approval and ensure maintenance of legal marketing status of all products, including Class I, II and III devices. Ability to partner and influence key stakeholders on NPD and Lifecycle teams. Clearly define and prioritize decision criteria and consider benefits, risks, and Credo of each alternative before making decisions. Consistently manage large amounts of changing, complex, and/or ambiguous information from multiple sources and make timely and effective decisions for the execution of project objectives. Ability to author and submit US, EU and International Regulatory submissions to Regulatory bodies. What’s in it for YOU? It’s important to us that you feel you can bring your whole self to work; at Johnson & Johnson we provide an environment for you to fulfill your career aspirations as well as promoting your physical and mental wellbeing. As part of our offering, you will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life. Examples include: online Digital GP, private healthcare, Retail Vouchers, Discounted & Subsidised Gym memberships and the opportunity to support community projects as part of our global Corporate Social Responsibility programme.