HERO

Job Detail

Location Galway
Salary Negotiable
Posted
Role Type Permanent
Contact Helga Reeves
email helga@hero.ie

RA Manager

Apply Now

Job ID: JOB-11924

RA Manager 

Our client a leading MCN is recruiting for a Regulatory Affairs Manager with direct responsibility for developing regulatory plans with a high level of complexity. You will plan and prepare documentation for international and domestic product registrations for new and modified products. This role would not have an immediate team to manage however as the role grows, this would be reviewed.  This role is based in Galway, commutable from Mayo and Clare.

Responsibilities:

  • Provides regulatory support for diagnostic product development and commercial diagnostic products
  • Develops regulatory strategies for products in development and for modified products to achieve clearance/approval in the US and internationally
  • Researches scientific and regulatory information in order to write, edit, and review submission documents
  • Compiles and publishes all material required for submissions, license renewals, and annual registrations
  • Works with governmental regulatory agencies and other third party accrediting bodies
  • Maintains approvals/licenses/authorizations for existing marketing authorizations
  • Ensures accuracy of US registration and device listing
  • Adds and maintains information contained in the Global Regulatory Information Database
  • Provides recommendations on labelling, manufacturing, and analytical and clinical study plans for regulatory compliance
  • Reviews validation reports for regulatory submission soundness
  • Assesses product, manufacturing and labelling changes for regulatory reporting impact and compliance to regulations
  • Reviews advertising and promotion to ensure compliance with product claims
  • Keeps informed of global regulatory information; prepares impact assessments
  • Represents the company on US trade associations and contributes to trade positions
  • Develops internal procedures and tools
  • Conducts informational or training sessions for stakeholders
  • Organizes and maintains hard copy and electronic department files
  • Contributes to management review for new or revised regulations and/or other quality system activities
  • Assists with hosting inspections, as needed
  • Assists with conducting internal/external audits, as needed
  • Assists with resource planning and budgeting, as needed
  • Carries out duties in compliance with established business policies
  • Demonstrates commitment to the development, implementation and effectiveness of the company’s Quality Management System per ISO, FDA, and other regulatory agencies
  • Responsible for exhibiting professional behaviour with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices
  • Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities
  • Other duties as assigned, according to the changing needs of the business

Education, Experience and Skills

  • Bachelor’s degree (BS/BA) in any scientific field.
  • 3-5 years’ experience in Regulatory Affairs within a Senior Specialist role.
  • Management experience would be highly advantageous
  • Strong knowledge of federal and international regulations
  • Strong knowledge of quality systems in a regulated manufacturing environment
  • Demonstrated written and verbal communication skills
  • Ability to work on multiple projects simultaneously
  • Possess a high degree of accuracy and attention to detail
  • Five plus years in an IVD or medical device manufacturing environment
  • Good knowledge of business models, resource planning and budgeting
  • Supervisor experience preferred

 For more information on this RA Manager role in Galway please contact Helga Reeves on 086 8168298  helga@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/ 

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Helga Reeves

JOB-11924

Apply Now

RA Manager

Helga Reeves

Role Type Permanent
Contact Helga Reeves
email helga@hero.ie
mobile +353 86 816 82 98
linkedIn profile click here

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