Regulatory Affairs Contractor Senior

RELEVANT INFORMATION:

Occupancy: 100%,
Start date: 01.03.2021
Initial duration: 6 months
This role is to be based in Sweden, Uppsala/Stockholm.

MAIN TASKS FOR THE ROLE:
- Prepare and assemble regulatory submissions for achieving registrations of Ophthalmic Viscoelastic Devices (OVDs) in EU
- Manage documents submitted in document management system
- Prepare Regulatory Impact assessments for EU
- Participate in design control of new or revised products developed or manufactured in Uppsala.
- Compile and maintain Technical files according to MDD/MDR
- Provide RA support during audits
- Support global RA teams with expert guidance
- Registrations and renewals

QUALIFICATIONS AND EXPERIENCE
Education:
- Bachelor’s degree or equivalent training in life sciences or medical device engineering or a long-term healthcare industry background is required.
- Experience with medical device submissions required.
- Minimum of 5 years of professional experience within Regulatory Affairs.
- Solid understanding of national medical device regulatory requirements & procedures to obtain market access.
- CE marking experience with NBs required.