Senior Regulatory Officer

𝗠𝗮𝗶𝗻 𝗗𝘂𝘁𝗶𝗲𝘀:
* Drive quality culture in accordance with our quality policies, guidelines and processes Champion compliance to applicable Global Regulations and standards (eg. US FDA, 21 CFR 820, ISO 13485:2016 and IVDR: In Vitro Diagnostics Regulation)
* Collaborate with the regulatory manager on all new IVDR regulations Support implementation of company regulatory strategies and providing guidance and expertise.
* Compiling and communicating regulatory requirements and gap analysis assessments (e.g. EU IVDR, global markets, standards, etc.) to multi-functional groups in a concise and precise manner.
* Review and approve the project documentation (risk management documentation, design reports, labelling, etc.).
* Ensure that updates to the Technical Files and international registrations are conducted appropriately.
* Communicate with relevant departments should any issues arise Ensure employees understand their duties/delegated tasks Provide coaching and support to all regulatory team Ensure any goals/deadlines are on target/being met

𝗘𝘀𝘀𝗲𝗻𝘁𝗶𝗮𝗹 𝗖𝗿𝗶𝘁𝗲𝗿𝗶𝗮:
* A minimum BSc in molecular biology or related discipline and/or a minimum 5 years' experience in a regulatory role Min 2 years' experience in a Medical Device or an In Vitro Diagnostic Company
* Working knowledge of ISO 13485 and ISO 14971 standards
* Experience with Post Market Surveillance and Vigilance activities
* Ability to work to tight deadlines
* Good initiative and team player
* Excellent communication and interpersonal skills
*Full clean driver's licence

𝗗𝗲𝘀𝗶𝗿𝗮𝗯𝗹𝗲 𝗖𝗿𝗶𝘁𝗲𝗿𝗶𝗮:
* MSc in molecular biology or related discipline
* Experience in preparation of medical device technical files and regulatory submissions MDD/MDR experience and/or IVDD/IVDR experience
* Experience with QMS and product audits from Notified Bodies

Adecco Ireland is acting as an Employment Agency in relation to this vacancy.