Senior Regulatory Affairs Specialist - Galway 

Join a leading global innovator where your expertise drives meaningful advancements in healthcare and positively impacts lives worldwide. 

Responsibilities of the role:

• 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.

TECHNICAL SKILLS

• Level 8 Honor’s Degree Science or Engineering bachelor's degree/master's
• 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 or similar regulated industry is required.
• You are a dynamic team player and can work effectively and pro-actively on activities both individually and in teams.
• Experience with FDA regulatory requirements, European Medical Devices Regulation (EU MDR), Regulation (EU) 2017/745 and international regulatory agency requirements

For more on this contact Regina at HERO 086 0100903 or jobs@hero.ie

For more information on this role please contact Regina Carroll  086 0100901 or jobs@hero.ie  Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

 Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval

 Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given.  You have supplied us with your personal data in the process of applying for a position.  Our client company may have personnel outside of the EEA who will review you data.  We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.