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Senior Regulatory Affairs Associate
Leeds, United Kingdom
Requisition ID: 1700204575W
Position: Senior Regulatory Affairs Associate
DePuy Synthes is a Johnson & Johnson company that is one of the leaders in the medical device industry. Our implants and instruments are used by orthopaedic surgeons to treat patients with conditions resulting from traumatic injuries, degenerative diseases, deformities, and sports related injuries. DePuy Synthes offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Our environment is entrepreneurial, learning-driven, and is as challenging as it is rewarding.
We have an exciting opportunity for a Senior Regulatory Affairs Associate to To coordinate worldwide product registrations and CE marking activities to ensure timely and systematic regulatory and Company requirements.
o Provide full support to all registration activities, CE marking and regulatory submissions throughout the world.
o Facilitate worldwide product registration activities by compiling appropriate dossiers, submissions and responses to regulatory bodies.
o Establish and maintain processes for submissions, interim notifications and periodic re-submissions.
o In conjunction with other departments, ensure that the company’s post marketing surveillance responsibilities are fulfilled and support vigilance activities.
o Maintain information on worldwide regulatory requirements and the status of product registrations.
o Liaise with all departments and project teams to co-ordinate timely applications for CE marking and other approvals.
o Provide support and advice to company colleagues, particularly product development, concerning CE marking and other world regulatory requirements.
o To maintain progress and developments of worldwide regulatory environments, and to address regulatory requirements as appropriate.
o To follow and promote Company, HS&E and Quality procedures and standards to enable the site to achieve and maintain excellent results.
o To carry out such further tasks that may be delegated to me by my immediate manager.
Qualifications And Experience:
• 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 tools.
What we’re about:
We are passionate about our work, and play vital roles across a range of professional disciplines, and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. We share a kind of DNA where we’re each
• Committed to caring
• Responsible to our communities
• Ready to apply our knowledge and know-how
• Unique in our background and experiences
• The drivers of our own success
• Passionate about doing what’s right
Make a unique mark in your career
If you want to be seen for the talent you bring to your work, be the driver of your own career, and work with others who share your passion for caring and success, then we invite you to join the Johnson & Johnson Talent Community by visiting www.careers.jnj.com
We respectively request Government Officials to identify themselves as such on application; for the purpose of 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 Medical, a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
Depuy Int'l Ltd. (8722)