Senior Reg Affairs Specialist

The role:

PE Global is currently recruiting for a Senior Reg Affairs Specialist on behalf of a leading medical device company based in Galway. This is an initial 12-month contract role.

Responsibilities:

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
• Leads or compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Monitors and improves tracking / control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Recommends strategies for earliest possible approvals of clinical trials applications.
• Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
• The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
• Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
• Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.
• Communicates with senior internal and external customers and vendors.

Education & Experience:

• Level 8 Honor’s Degree Science or Engineering bachelor’s degree/master’s with a minimum of 5 years of relevant experience, preferably with Class III devices. A Regulatory Affairs qualification is desirable, but not mandatory
• Regulatory experience in Medical Devices, Pharmaceuticals, Software in a medical device or similar regulated industry is required
• You have strong technical knowledge. You are skilled in thinking critically and making sound decisions. Ability to comprehend principles of engineering, physiology, and medical device use.
• You collaborate with global cross functional teams and create alignment with team members.
• Experience with FDA regulatory requirements, European Medical Devices Regulation (EU MDR), Regulation (EU) 2017/745 and international regulatory agency requirements
• May provide guidance, coaching and training to other employees within job area.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***