11 days ago
Regulatory Affairs Specialist
About Your New Employer
In your job as Regulatory Affairs Specialist, you will be working for a Medical Device manufacturer based in Galway City. In your new job you will be working with devices used to save and enhance lives.
About Your New Job
- You will prepare regulatory submissions to regulatory authorities within the EMEA region.
- As Reg Affairs Specialist, you will assist with determination of regulatory pathways for various projects including product classification and type of regulatory submission or rationale required.
- You will participate on various teams to define regulatory requirements for countries in the EMEA region, and process international submissions.
- It's your job to identify guidance documents, international standards, consensus standards and assists teams with their interpretation.
- You will interact with various levels of management, external agencies and companies.
- Your job is to assist with developing, maintaining and analyzing department systems and provides training when needed.
- You will work on developing regulations and revises systems as necessary.
- You will participate in and assists with Competent Authority inspections, Notified Body Audits and other governmental inspections as directed or as applicable.
- You will perform other related duties and tasks, as required.
What You Need
- A Level 8 Degree in STEM
- Experience working in Reg Affairs in the Medical Device industry.
- knowledge of the Medical Devices Directive (93/42/EEC), Medical Device Regulation (2017/745) and ISO 13485 Quality System Standard
What's on Offer
In addition to all statutory entitlements and a meaningful job where you help save lives, you will get:
- Fully covered Health Insurance
- Pension Scheme
- Life Assurance
- Educational Assistance
- Career Progression Opportunities
Apply for your new job now by clicking the apply button, or contact Dean Flynn at Sigmar Recruitment for more information T: +353 91 455306 E: firstname.lastname@example.org
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