Jobs
My ads
My job alerts
Sign in
Find a job Employers
Find

Leading regulatory compliance specialist

Galway
beBeeRegulatory
Compliance specialist
Posted: 6 October
Offer description

Job Summary

We are seeking a highly motivated Regulatory Affairs Manager to lead and oversee all regulatory compliance activities for our company in Galway, Ireland.


Main Responsibilities:

* Strategic Compliance: Define and execute regulatory strategies in support of new product development and post-market activities.
* Submission Management: Manage regulatory submissions (e.g. 510(k), CE Mark) and global product registrations.
* Regulatory Agency Liaison: Act as the primary contact for regulatory agencies, including authorities in the U.S. and Europe.
* Compliance Monitoring: Monitor and interpret evolving regulatory requirements and apply them to ensure company compliance.
* Vigilance and Post-Market Surveillance: Partner with Quality Assurance to ensure post-market surveillance and vigilance activities meet applicable standards.
* Regulatory Review: Review and approve promotional and advertising materials from a regulatory perspective.
* Resource Allocation: Identify and allocate internal and external resources needed to maintain a robust regulatory function.


Requirements:

* A degree in Engineering, Life Sciences, or a health-related field.
* At least 10 years of experience in the medical device industry, with a minimum of 3 years in a leadership or management role.
* In-depth knowledge of US FDA and EU medical device regulations (including MDR).
* A proven ability to handle complex regulatory submissions and interactions.
* Excellent organizational, leadership, and communication skills.

A self-starter with a hands-on approach and the ability to thrive in a dynamic environment. Previous experience in an SME or medtech startup is highly desirable.

Apply
Create an E-mail Alert
Job alert activated
Saved
Save
Similar job
Compliance specialist
Gort
Natus Medical Incorporated
Compliance specialist
€40,000 - €60,000 a year
Similar job
Compliance specialist
Galway
Natus Medical Incorporated
Compliance specialist
Similar job
Senior medical device compliance specialist
Galway
beBeeRegulatory
Compliance specialist
Similar jobs
It jobs in Galway
jobs Galway
jobs County Galway
jobs Connaught
Home > Jobs > It jobs > Compliance specialist jobs > Compliance specialist jobs in Galway > Leading Regulatory Compliance Specialist

About Jobijoba

  • Company Reviews

Search for jobs

  • Jobs by Job Title
  • Jobs by Industry
  • Jobs by Company
  • Jobs by Location

Contact / Partnership

  • Contact
  • Publish your job offers on Jobijoba

Legal notice - Terms of Service - Privacy Policy - Manage my cookies - Accessibility: Not compliant

© 2025 Jobijoba - All Rights Reserved

Apply
Create an E-mail Alert
Job alert activated
Saved
Save