Johnson & Johnson Careers

Regulatory Affairs Manager

La Tronche, France
Regulatory Affairs


Job Description

Requisition ID: 1805677053W


 
Orthotaxy, a member of Johnson & Johnson's Family of Companies, is recruiting for an Electrical Engineer, Robotic-Assisted Surgery to be located in Grenoble, France.

Orthotaxy has just joined the companies of Johnson & Johnson. The robotic platform developed by Orthotaxy is focused on total and partial knee replacement, but the plan is to broaden its application to a range of orthopaedic surgical procedures. Orthotaxy will offer the next-generation robotic-assisted orthopaedic surgery solution.
 
 
Job purpose:
To effectively manage and expedite the regulatory strategy (EU, US and ROW) of the Company's robotic assisted surgical solutions. Maintenance and lifecycle management of associated documentation whilst maintaining complete regulatory compliance throughout.
 
 

Principal Accountabilities:

  • To manage the Regulatory Affairs of the Robony development ensuring it fully supports the business objectives.
  • To establish and maintain good relationships with Regulatory Authorities, Regulatory colleagues at DePuy Franchise companies and distributors; and to provide support and advice to worldwide company colleagues.
  • To effectively manage worldwide registration activities.
  • To ensure product approval and registration is obtained for all new products by ensuring that all new product dossiers are created where appropriate in line with local country requirements.
  • To drive effective registration strategies to ensure regulatory programs are standardized to obtain earliest possible approval.
  • To establish and maintain processes for the status and maintenance of registrations, interim notifications and periodic re-submissions.
  • To strategically work with New Product Development in the development of new products and technologies delivering first in class regulatory strategy for product commercialization.
  • To liaise as appropriate with all internal departments to provide regulatory direction, input and support.
  • To 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.
  • Implement preventative and corrective action programs 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.
To carry out such further tasks that may be delegated by immediate manager.
 

Internal And External Relationships

  • Reports directly to the Regulatory Affairs Associate Director, DePuy Synthes Joint Reconstruction.
  • Direct co-ordination of submissions registrations with external Regulatory Bodies, distributors and subsidiaries.
Liaise with personnel in all internal departments and Regulatory colleagues at DePuy Franchise companies.
 



 
 

Qualifications

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 including electromedical and software. Experience in surgical navigation or surgical robotic devices would be advantageous.
  • Experience of FDA submissions ( 510(k) and PMA in addition to management of change.
  • Commanding knowledge of worldwide regulatory  procedures, especially for medical devices inclusive of MDD and MDR.
  • 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.
  • Relevant experience of a team environment to ensure effective contribution and commitment of staff.
  • Possess computer competency in Microsoft office software, data collection and general analysis Tools.




Primary Location
France-Rhône-Alpes-La Tronche
Organization
Orthotaxy(7103).
Job Function
Regulatory Affairs
Requisition ID
1805677053W