Johnson & Johnson
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 jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
Leeds, West Yorkshire, United Kingdom
Job Description:
Position: Regulatory Affairs Assistant
ABOUT MEDTECH
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
The Regulatory Affairs Assistant will help support New Product Development, Life Cycle Management, and product registration activities across the Depuy Synthes Portfolio. Help support CE marking, UK CA mark and USA FDA submissions to project plans in accordance with Regulatory and Company requirements.
DUTIES & RESPONSIBILITIES
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 US FDA submissions.
Facilitate worldwide product registration activities by compiling appropriate dossiers, submissions, and responses to regulatory bodies.
Maintain processes for submissions, interim notifications, change notifications and periodic re-submissions.
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 global regulatory requirements.
Provide support to maintenance of regulatory metrics and databases. Preparation of associated reports.
Support compliance and audit activities during planning, preparation and response phases.
To be aware of progress and developments of worldwide regulatory requirements.
Responsible for communicating business related issues or opportunities to next management level.
Performs other duties assigned as needed.
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.
EXPERIENCE
Regulatory experience covering medical devices.
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 tools.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES AND AFFILIATIONS
Excellent planning and organisational, communication skills,
Product awareness and thorough knowledge of respective regulatory frameworks.
Thorough and flexible.
Cross culturally aware.
Team player.
Enthusiastic and committed.
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.
Required Skills:
Preferred Skills: