Regulatory Affairs Specialist – Galway

Recruiter
PE Global
Employment Type
Contract
Salary
Not disclosed
PE Global logo

PE Global are currently recruiting for a Regulatory Affairs Specialist for a client site in Galway

12 month initial contract – Hybrid

 

At our Regulatory Affairs department, our mission is to develop innovative strategies for regulatory approval, anticipate and respond to changing regulatory requirements, and provide strategic leadership to influence the global regulatory environment to benefit the patients we serve. Regulatory Affairs is a key function within the business and this role is supporting the Structural Heart business.

• Directs or performs coordination and preparation of document packages for regulatory submissions.
• Teams with business unit Regulatory Affair Specialists and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products. Work with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies.
• Leads or compiles all materials required in submissions, license renewal and annual registrations.
• Supports change control activities to support global approval and implementation of product and process changes
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol/evaluation reports for regulatory compliance.
• Keeps abreast of regulatory procedures and changes. Develop internal procedures to ensure continuous compliance with all regulatory requirements.
• May direct interaction with regulatory agencies on defined matters.
• Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed.
• Monitors and improves tracking / control systems.
• Identifies and develops best practices within the Regulatory Affairs Department including continuous development initiatives.

Key Skills & Experience
• We are looking for a person qualified to Level 8 Science or Engineering Bachelor’s Degree/Masters with a minimum of 2 years of relevant experience. A Regulatory Affairs qualification is desirable, but not mandatory.
• Regulatory experience in Medical Devices and or Pharmaceuticals is required, and related relevant experience will also be considered.
• You are a dynamic team player and can work effectively and pro-actively on activities both individually and in teams.
• You have strong technical knowledge. You are skilled in thinking critically and making sound decisions.
• You collaborate with others and create alignment with team members.
• You set high standards and drive accountability in the execution of your responsibilities and you model ethical behavior.
• Ability to work independently and under general direction only
• You are a good communicator and fluent in English, both in writing and speaking with strong organizational skills.

 

Interested candidates should send their CV to Audrey at @ or call

Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert.