Job Description
The Regulatory Affairs Specialist will be responsible for activities which lead to, and maintain regulatory approval to market devices. Additionally, the Regulatory Affairs Specialist will be responsible for assessment of device changes for regulatory implications.
Responsibilities
Support strategies for regulatory approval of medical devices.
Coordinate submission activities for a variety of device regulatory approvals including: US premarket approvals and supplements, international design dossiers, post-approval support through change management review and international regulatory approval activities.
Serve as internal consultant on regulatory issues such as review of proposed device and manufacturing changes.
Develop and deliver presentations to management - topics may include submission strategies, compliance issues or highlight updates to regulations as well as provide guidance on new regulatory requirements.
Communicate submission requirements to internal customers such as product development teams.
Work with new product engineering and project teams to provide guidance on potential regulatory requirements in a number of product classifications.
Research regulatory requirements for assigned geographies.
Monitor emerging trends and integrate new requirements into department procedures and toolkits.
Participate in training and mentoring of staff.
Qualifications:
Degree Level BSc, BEng or related discipline.
3 years regulatory affairs experience
For further information on this Regulatory Affairs Specialist position please contact Laurentina Kennedy at The RFT Group on 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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