Senior Regulatory Affairs Specialist - Johnson & Johnson

About the Johnson & Johnson Medical Devices Companies – Vision (Uppsala site) 
Johnson & Johnson is a company committed to doing good for the world. We blend Heart, Science and Ingenuity to profoundly change the trajectory of health for humanity.  
 
Johnson & Johnson Vision is a leading global optical company that develops life changing techniques for all ages. We provide eye surgeons and their patients with a complete solution that includes a range of advanced products and services developed to help people of all ages with sight defects. We offer market leading technique for laser surgery, equipment for cataract operations and intraocular lenses. We also offer a program for education and support that help eye surgeons to master the full range of the technology. 
 
Johnson & Johnson Vision in Uppsala produce the ophthalmic viscoelastic device Healon. We manufacture our products from scratch. A substance is produced from raw materials and is through different steps in production processed to finished products. The whole process takes several days and monitored closely. A variety of quality assurance measures are made continuously. It is important that the product is free from particles, fibers and odor. Improvements to the product and the process are made continuously to lift the organization to a more efficient level and to position ourselves in front of our competitors. At our site in Uppsala, there are many different tasks and employees with different experiences and skills. We are about 120 employees located in Uppsala and 8 400 employees worldwide within Johnson & Johnson Vision.  


Senior Regulatory Affairs Specialist
The responsibility of the role is to perform the CE marking of our Ophthalmic Viscoelastic Devices (OVDs) and supporting the regional Regulatory teams on the registrations of our OVD products globally. The incumbent will be the subject matter expert for OVDs on all regulatory related topics and will interact with many different global colleagues. The reporting line is to the Director Regulatory Affairs for the EMEA region. The work location is in Uppsala, Sweden at our AMO Uppsala manufacturing site and there is another Regulatory Affairs colleague based on site. 


Objectives of the Position
Prepares and assembles regulatory submissions for achieving registrations for OVDs in EMEA and globally.
Supports the development of new products on all Regulatory related matters in close contact with R&D and Reg Ops.
Create, maintain and update of Technical Files for OVDs
Support the MDR project team for OVDs
Labeling review for Regulatory compliance in close contact with the labeling team
Participation in the design control process and supporting significant changes to our OVD product portfolio, e.g. by preparing significant change submissions to our Notified Body
Developing and maintaining Regulatory SOPs 
Audit support on all regulatory topics



Qualifications
Bachelor´s degree in life sciences or medical device engineering or a long-term healthcare industry background is required. 
A minimum of 3 years of experience within Regulatory Affairs and working with Notified Bodies on the CE marking of medical devices (required).
Solid understanding of the global and national medial device regulatory requirements and procedures to obtain market access



What you will need to succeed 
Fluent English skills, additional languages are an advantage
Ability to act in a multicultural and cross functional environment are essential.
Strong analytical and communication skills, project manager skills are of advantage
Good organizational skills, flexibility, high commitment
Ability to work highly independently
Travelling required to participate in meetings with Competent Authorities, the Notified Body or at internal Regulatory meetings (5% of time)



Are you ready to impact the world? 
Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career. 


If you are interested in this position, please apply with an updated CV and Cover letter. The selection process will start during the standard 30-days posting period, please send in your application as soon as possible. We reserve the rights to close the advert earlier. All applicants can expect feedback on the application.  


We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.