Junior Regulatory Affairs Specialist

Junior Regulatory Affairs Specialist About Your New Employer This medical device multinational employs close to 3,000 people in their Galway facility alone. This job is a 12 month contract role based in their Coronary department and will focus on MDR activities. About Your New Job as a Regulatory Affairs Specialist: Direct or perform coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. Lead or compile all materials required in submissions, license renewal and annual registrations. Recommend changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. Monitor and improve tracking / control systems. Keep abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Recommend strategies for earliest possible approvals of clinical trials applications. What Skills You Need: Level 8 NFQ Degree in Engineering or Science. Minimum two years in a similar position in the medical device industry. What's Next? Click 'apply now' or more information, please contact Emma on Skills: "Submissions" "MDR" "ISO 13485"