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Senior Regulatory Affairs Associate - Medical Devices - Blackpool
Blackpool, United Kingdom
Requisition ID: 1805647554W
Senior Regulatory Affairs Associate
Location : Blackpool, UK
Pay Grade : 25
Closing Date : 9th May 2018
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 innovative, 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 manage 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 and be able to work both as an individual leader and be a strong team player. Stakeholder management will be key to your success.
You will welcome and even seek out challenging situations as an opportunity to grow, something that will be recognized by the appreciative and rewarding working environment that is DePuy Synthes.
As a Senior Regulatory Affairs Associate, your typical day may include:
• Effective management of regulatory activities and providing regulatory advice to support business objectives.
• Supporting and coordinating regulatory approval for new products and changes to existing products by ensuring that dossiers are created where appropriate in line with local country requirements (incl. CE mark and US).
• Developing and implementing regulatory strategies and plans, with support as necessary
• Establishing and maintaining good relationships with, and represent the Regulatory Department to worldwide regulatory colleagues at DePuy Synthes companies, distributors and external regulatory bodies.
• Liaising with internal departments and worldwide company colleagues to provide regulatory direction, input, support and advice.
• Establish and maintain processes for maintenance of registrations.
• Be aware of progress and developments of worldwide regulatory requirements and address changes as appropriate.
• Provide regulatory input for post market surveillance and vigilance activities, audits, non-conformance disposition, corrective and preventative actions, post market product changes and product literature approval.
Qualifications and experience
• A First-class degree in a relevant Scientific discipline.
• Extensive regulatory experience in worldwide registrations
• Experience with medical Devices Directive
• Drug-device and/or Pharmaceuticals registrations experience
• Able to demonstrate regulatory input into new product development projects.
• Able to demonstrate regulatory actives undertaken that have been satisfactorily completed within agreed timescales.
In return for all this great work, you’ll own and you’ll grow by:
Within DePuy Synthes we are always looking for future leaders so this position will give you great visibility to showcase your talents and develop your career. We will support you to develop both technically and personally.
With our support, you will have autonomy to shape the site, 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 ready for your career to excel to the next level then this is one in a life time chance to join the world’s leading health care provider.
What we’re about:
We are passionate about our work, and play vital roles across a range of professional disciplines caring deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and influential careers. We are
• 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
CLOSING DATE: 9th May 2018
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.
We respectfully request Government Officials to identify themselves as such on application; for the purposes of the Foreign Corrupt Practices Act
Depuy Int'l Ltd. (8722)