Regulatory Affairs Associate - Johnson & Johnson MedTech

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.
• Executes the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers.
• Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.
• Defines data and information needed for regulatory approvals.
• Assists in the development of labeling specifications and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.
• Provide Regulatory Affairs support during internal and external audits.
• Plans schedules for regulatory deliverables on a project and monitors project through completion.
• Assists in the development of best practices for Regulatory Affairs processes.
• Represents Regulatory Affairs on cross-functional project teams.
• Partners with other functions to define and obtain data to assist with regulatory submissions.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed., 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 (EU and USA).
• Ability to partner and influence key stakeholders on NPD and Lifecycle teams.
• Clearly defines and prioritizes decision criteria and considers benefits, risks, and Credo of each alternative before making decisions.
• Considers all of the available facts when situations are ambiguous in order to make the best possible decision (for example, when regulations are unclear).
• Consistently manages large amounts of changing, complex, and/or ambiguous information from multiple sources and makes 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 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.
• Leverages scientific and technical understanding of regulated products under scope of responsibility to provide strategic guidance and support for product development and life- cycle management of products.
• Integrates and executes results-oriented Regulatory Affairs strategies that are aligned with organizational objectives. Takes accountability for the achievement of business goals and objectives.
  
  J&J Family of Companies Regulatory Affairs Associate - Johnson & Johnson MedTech in Blackpool, United Kingdom
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. 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., 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.