Johnson & Johnson MedTech is currently seeking a Senior Regulatory Affairs Associate.

Location: Leeds Office, (hybrid model, 3 days in office 2 at home)

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, andsolutions 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:

The Regulatory Affairs Senior Associate will execute regulatory activities to support currently marketed devices and new product development in the Johnson & Johnson MedTech | Orthopaedics 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 you will be Doing:

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• 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.

• To follow and promote Company, HS& E and Quality procedures and standards to enable the site to achieve and maintain excellent results.

• To carry out such further tasks that may be delegated to me by my immediate manager.

• 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.

• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if 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. What you will bring:

• A 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.
• 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 tools.
• Communication - listener, learner and thinker.
• Product awareness and thorough knowledge of respective regulatory frameworks.
• Demonstrated expertise in medical device regulatory requirements and processes.
• Excellent project management skills by demonstrated competence in managing multiple projects simultaneously.
• Capable of providing direction and training to junior colleagues.
• Experience in worldwide regulatory systems.

Other considerations:

• Reports directly to the Regulatory Affairs Manager/ Assistant Director / Director, and co-ordinates with the other Regulatory Affairs Associates. Liaise with personnel in all departments.
• Co-ordinate registrations with external regulatory bodies, distributors and subsidiaries.
• UK, France, US - Flexible or remote working arrangements may apply.
• Domestic and international travel may be occasionally required.
• Co-ordinate registrations with external regulatory bodies, distributors and subsidiaries.

***Interviews will be in January 2025***

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.