Regulatory Compliance Specialist
1 week ago
This is a pivotal role for an innovative medical technology company based in Cork, Ireland.
As a Regulatory Associate, you will be responsible for ensuring the company's products comply with regulatory requirements worldwide.
The ideal candidate will have a strong understanding of medical device regulations and standards, including EU MDR, US FDA, and ISO 13485.
Experience working directly with regulatory agencies and managing projects to deadlines is essential.
You will support day-to-day regulatory activities, implement compliance enhancements, and work closely with interdisciplinary teams to ensure the effectiveness of the quality management system (QMS).
Additionally, you will monitor global regulatory trends, evaluate manufacturing and labelling changes, and maintain awareness of changes in domestic and international regulations.
Key responsibilities include ensuring product manufacture and testing meets CE mark and FDA submissions requirements.
Work with suppliers to ensure products' process validations and risk management files are to the standard of regulatory submissions.
Provide strategic regulatory insight to team members regarding product development plans.
Maintain the day-to-day activities of post-market surveillance, including logging customer complaints and adverse events, coordinating investigations, and addressing initiatives to test, change, and improve products as required.
Required Skills and Qualifications:- Bachelor's degree in engineering or science
- Minimum three years of regulatory experience in the medical device industry
- Regulatory certifications in EU MDR and US FDA desirable
This role offers excellent opportunities for career growth and professional development in a dynamic and fast-paced environment.
As a member of our team, you will receive comprehensive training and support to help you succeed in your role.
We offer a competitive salary and benefits package, including health insurance, pension scheme, and annual leave.
Other Requirements:Ability to work independently and as part of a team
Excellent organizational and communication skills
Highly motivated and self-driven individual
Detail-oriented and analytical thinker
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