Johnson & Johnson MedTech is recruiting for a Regulatory Affairs Manager, located in the United Kingdom Or Republic of Ireland (UK/IRE), to be part of the team in this dynamic dual legislative environment. Who Are We? 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. Learn more at https://www.jnj.com/ 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 and Summary This role will involve monitoring of the Regulatory Environment and fostering feedback to relevant partners, deployment of activities to ensure local regulatory compliance. Responsible for Regulatory Affairs strategy for Medical devices, Medicines and Human Tissues as defined by the product portfolio. Co-ordinate the activities of the local team to ensure timely compliance and innovation of processes and assist and deputise as the UK Responsible Person on behalf of Johnson & Johnson Legal Manufacturers. Key Responsibilities monitoring of and deployment of local regulatory requirements, advising appropriate partners. Coordination of the work of the team in deploying J&J standard requirements to project timelines. Interprets regulatory requirements and applies them to RA strategies and impact assessments, on changes to products, business models, licences considering impact to HCPS and patients. Takes ownership and responsibility for decisions regarding work processes or operational plans and schedules. Responsible for institutional relationships with external organisations. Ensure company compliance in all activities related to Regulatory input. Preferred hybrid working pattern with an office location in Wokingham, moving to Maidenhead in 2026, in the United Kingdom Or the Dublin office in Ireland, with monthly attendance to the UK UK office for team F2F connections. Further potential to consider remote location within the UK or IRE, with monthly attendance to the UK office for the right candidate. Assists the UKRP; responsible for ensuring agreements in-place, registration of products on the UK market, removal of obsoleted products from the registrations, takes on defined obligations of the manufacturer to ensure products are appropriate to be placed on the UK market, acts accordingly. Assisting with monitoring of the UK environment for future legislation, impact assessments for the Marathon team and the UKCA program. What you will be doing - Deployment of local regulatory requirements. - Monitoring local Regulatory Environment and feed-back to relevant partners. - Coordination of the deployment of J&J standard requirements. - Ensures organization compliance with all applicable regulations and J&J policies. - Interprets new regulatory requirements and determines strategies. - Makes decisions regarding work processes or operational plans and schedules. - Responsibility of Institutional relationships - with CA/EC in collaboration with corporate GA&P. - Performs Impact assessments of regulatory changes on products, business/licenses and patients/HCP. - May manage internal and contingency RA resources. Qualifications Who we are looking for Education: - Degree of Pharmacist or Scientific Degree or Law Degree or equivalent Experience and Skills: - People management experience - UK Regulation - MDD Directive & MDR Regulation - Environmental Directives - Human Tissues and Cells Directive - Medicines Directive - AI legislation Preferred: - Experience of sophisticated project management - Experience of working with Notified Bodies - Experience of supporting Tenders - High degree of initiative. - Outstanding collaboration to cultivate the strength of a network - Communication and negotiation skills. - Open minded, listens to others - Customer focused - Able to handle complexity organization structures - At ease in an international environment. - Well organized, sense for detail - Diplomacy Other: - 10% Travel What type of mark will YOU make? By joining Johnson & Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our commitment to be the world's healthiest workforce you can strengthen your body as well and your mind. When you work at Johnson & Johnson you can touch over a Billion lives worldwide every day. And when you apply your talent to our collective purpose there's no end to the lasting impact we can make together. And that changes everything. 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 fulfil 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 of this include: online Digital GP, private healthcare, Retail Vouchers, Discounted & Subsidised Gym memberships and you can get to support community projects as part of our global Corporate Social Responsibility programme. We respectively request Government Officials to identify themselves as such on application; for the Foreign Corrupt Practices Act. If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.