Regulatory Affairs Assistant| J&J MedTech|

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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.

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Position: Regulatory Affairs Assistant

ABOUT MEDTECH

Fueled by innovation at the intersection of biology and technology were 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 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 worlds 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 theres no end to the lasting impact we can make together. And that changes everything.

Whats in it for YOU

Its 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.

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