Are you an experienced regulatory affairs professional with passion for medical devices?
We are looking for a medical devices Regulatory Affairs specialist to join our team in Leeds in order to effectively manage regulatory activities to ensure the Department supports business objectives.
You will be responsible for ensuring product approval and registration is obtained for all new products by ensuring that new product dossiers are created where appropriate in line with local country requirements.
This role will drive effective registration strategies to ensure regulatory projects are standardized to obtain the early approval. It will also involve maintaining processes for the status and maintenance of registrations, interim notifications and periodic re-submissions.
As a product lead, you will strategically work with New Product Development in the development of new products and technologies delivering first in class regulatory strategy for product commercialization.
Develops and implements regulatory strategies and plans in support of functional imperatives for Joint Reconstruction for changes to manufacturing sites, processes, global product transfers and legal manufacturer transfers to DePuy (Ireland).Partners with Regulatory teams in developing strategies ensuring clear visibility to risks and early identification of regulatory challenges.
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.
Work closely with other departments to support the company’s post-marketing surveillance responsibilities and vigilance activities. Liaising with all internal-partners to provide regulatory direction, input and support and represent the Regulatory Department to external Regulatory Bodies and customers.
To maintain progress and developments of worldwide regulatory environments, and to address regulatory requirements as appropriate and implement preventative and corrective actions as needed.
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.
- A good first degree in a relevant discipline, or equivalent.
- Significant regulatory affairs experience covering medical devices.
- Commanding knowledge and experience of worldwide regulatory procedures, especially for medical devices.
- Able to demonstrate projects undertaken have been satisfactorily completed within agreed timescales.
- Relevant experience gained in supervising Regulatory staff to ensure effective contribution and coordination.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Depuy Int'l Ltd. (8722)