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Thomas Gallagher
Life Science

+353870612325
[email protected]
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Details

Senior Reguatory Specialist


Reference:Thomas - A011798 Location: Galway City
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: EHS Specialist, Regulatory Affairs, Regulatory Affairs Clinical Research, Regulatory Affairs Consultant, Regulatory Affairs Specialist

Role: Senior Regulatory Specialist

Location: Dangan, Galway

Benefits: Competitive salary, Bonus up to 10%, Healthcare contribution, stock options and a flexible office and home working environment.



Company:

Founded in 2018 My client are a growing business with an exciting technology developing innovative catheter-based technology to remove clots from the brain following Acute Ischemic Stroke. The technology is designed to provide superior clinical outcomes in shorter procedural times, resulting in safe, cost-effective therapy.



Role:

As a Senior Regulatory Specialist your responsibility is to oversee regulatory filings for my clients products which requires a high level of innovative thought and problem-solving skills products. Over the next 2 years my client with have multiple submissions to US and EU FDA where you will gain amazing experience working in an exciting new company.



Responsibilities:

- Contribute to US and EU regulatory strategies for product submissions through identification of relevant test requirements


- Compile and coordinate regulatory filings to FDA, including 510(k) premarket notifications, IDE applications, IDE supplements, Annual Progress Reports, and subsequent FDA correspondence


- Coordinate and compile CE mark submissions and subsequent Notified Body interactions.
Submit change notifications to the Notified Body


- Prepare and coordinate updates to Technical Documentation according to MDR requirements




Requirements:


- Degree in Engineering or Science discipline


- Minimum of 3 years’ experience in the medical device industry


- Experience in preparation of regulatory submission


- Understanding of and ability to interpret and implement FDA, ISO, MDD and MDR requirements



To apply forward an up to date CV to the link provided or contact me at [email protected]