Senior Regulatory Affairs Associate | Johnson & Johnson MedTech | Orthopaedics in Leeds

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.

Johnson & Johnson MedTech | Orthopaedics is seeking a Regulatory Affairs Senior Associate based in Leeds (Hybrid 3 days in the office). Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone Orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes, and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans.

About Orthopaedics: Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their journey to wellness.

Role Purpose: The Regulatory Affairs Senior Associate will execute regulatory activities to support currently marketed devices and new product development in the DePuy Synthes Joint Reconstruction 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 and activities that directly impact the operational results of the business.

What To Expect:

• Provide full support to all registration activities, CE marking and regulatory submissions throughout the world.
• Facilitate worldwide product registration activities by compiling appropriate dossiers, submissions and responses to regulatory bodies.
• Establish and maintain processes for submissions, interim notifications and periodic resubmissions.
• In conjunction with other departments, ensure that the company's post marketing surveillance responsibilities are fulfilled and support vigilance activities.
• Maintain information on worldwide regulatory requirements and the status of product registrations.
• Liaise with all departments and project teams to co-ordinate timely applications for CE marking and other approvals.
• Provide support and advice to company colleagues, particularly product development, concerning CE marking and other world regulatory requirements.
• To maintain progress and developments of worldwide regulatory environments, and to address regulatory requirements as appropriate.

Who Are We Looking For?

• A good first degree in a relevant scientific discipline and/or significant area of expertise developed through experience and positive track record.
• Significant regulatory experience covering medical devices and/or pharmaceuticals.
• Commanding knowledge of worldwide regulatory procedures, especially for medical devices.
• Experience gained working in worldwide markets, and able to demonstrate proven track records of achievements.
• Able to demonstrate projects undertaken have been satisfactorily completed within agreed timescales.
• Possess computer competency in Microsoft Office software, data collection and general analysis.

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.