Johnson & Johnson Careers
Senior Regulatory Affairs Associate
Leeds, United Kingdom
Requisition ID: 1805703596W
DePuy Synthes a Johnson & Johnson company are the largest, most innovative and comprehensive orthopedic and neurological business in the world. 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. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop creative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
We have an amazing opportunity for a Senior Regulatory Affairs Associate. Reporting in to the Regulatory Affairs Manager, you will lead worldwide product registrations and CE marking activates to ensure timely and systematic approvals are made in accordance with regulatory and business requirements.
WHAT YOU’RE GREAT AT:
• You will be results driven and be able to apply your excellent planning, organizational and time management skills to ensure new products obtain the necessary regulatory registrations in line with business objectives.
• You have an innate ability to develop and implement effective strategies and can communicate these effectively to your internal department, worldwide company colleagues and regulatory authorities.
• You will have a strong sense of personal responsibility, be an individual leader and be a strong team member. Partner management will be key to your success.
• You will welcome and even seek out challenging situations as an opportunity to grow, something recognizable by the appreciative and rewarding working environment that is DePuy Synthes.
• Effectively manage regulatory activities to ensure the department supports business objectives by providing full support to CE marking, registration activities and regulatory submissions.
• Collaborate with New Product Development in the development of new products and technologies delivering effective regulatory strategy for product commercialization.
• Establish and maintain processes for the status and maintenance of registrations, interim notifications and periodic re-submissions.
• Assess, develop and implement regulatory strategies and plans for changes to manufacturing sites, processes, global product transfers and legal manufacturer transfers.
• To establish and maintain good relationships with Regulatory Authorities, Regulatory colleagues at DePuy Synthes companies and distributors; and to provide support and advice to worldwide company colleagues.
• In conjunction with other departments, support the company’s post marketing surveillance responsibilities and vigilance activities.
• To liaise as appropriate with all internal departments to provide regulatory direction, input and support.
• To maintain awareness of 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 and adhered to in a fair and consistent manner within the Regulatory Department.
QUALIFICATIONS AND EXPERIENCE
Are you interested in the next step? Do you have the following experience and background?
• A good first degree in a relevant discipline or significant regulatory expertise developed through experience and a positive track record.
• Drug-device and/or Pharmaceuticals experience gained in Regulatory Affairs or Quality functions.
• Significant regulatory & change management 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.
Within DePuy Synthes we are always looking for future leaders so this position will give you phenomenal visibility to showcase your talents and develop your career. We will support you to develop both technically and personally. With our support, you will craft the site with autonomy, you will grow this role and your success will be visible across the organization. This really is a chance to join a growing team and take it to full maturity.
If you are waiting for your career to excel to the next level then this is one in a lifetime opportunity to join the world’s leading health care provider.
Depuy Int'l Ltd. (8722)