Job Detail

Location Galway
Salary Negotiable
Posted
Role Type Contract
Contact Shane Connolly
email contracting@hero.ie

Regulatory Affairs Specialist

Job ID: JOB-11705
Regulatory Affairs Specialist

A leading medical device manufacturer is recruiting for a Regulatory Affairs Specialist to join their Galway team on a 6 month contract.

Purpose Statement

Responsible for Regulatory Affairs support of the site, submissions and regulatory compliance.

Key Responsibilities

  • Working as part of a team responsible for Regulatory Activities and issues occurring. Includes review/maintenance of Technical Files and providing information to US/ International Regulatory Affairs groups for other submission activities as well as regulatory issues relating to labeling, product releases and change requests.
  • Assist in preparation of Design Dossiers/Technical Files for all site products, in conjunction with divisional RA personnel and site QA personnel.
  • Convert MDD Regulatory files to EU MDR 2017/745 regulations requirements.
  • Write 30 Day Notices for Class III PMA Products, as well as writing Annual Reports for class III PMA Products.
  • Review and approve documentation related to product release/changes through the CR process.
  • Provide input, review and approve facility regulatory activities such as labelling.
  • Provide Emerging Markets submission information to U.S. based and Emerging Markets based International Regulatory Affairs personnel for site products.
  • Provide updates on regulatory requirement changes, either on individual product specification or quality systems.
  • Support the QA function during external agency audits.

Experience & Key Requirements

  • Minimum qualification required: Level 8 qualification preferably in Science or Engineering.
  • Minimum 3 years experience in a Health Care environment in a technical function
  • Experience in MDD ,FDA, ISO, environment
  • Strong team member with the ability to identify and drive regulatory compliance improvements
  • Good administrative/organizational ability with excellent attention to detail.

For more information on this role in Galway please contact Clara Burke on 086 8168273/ science@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

Shane Connolly

JOB-11705

Regulatory Affairs Specialist

Shane Connolly

Role Type Contract
Contact Shane Connolly
email contracting@hero.ie
mobile +353 87 219 74 21
linkedIn profile click here

Senior Quality Engineer – Process Validation

Galway

Job ID: JOB-11736 Senior Quality Engineer – Process Validation A leading medical device manufacturer in Galway is recruiting for a…

 

Read More

Senior Operations Manager

Galway

Job ID: JOB-11735 Senior Operations Manager Our client a medical device MNC is recruiting for a leadership role in Galway….

 

Read More

Planner/Buyer

Galway

Job ID: JOB-11731 Planner/Buyer Our client in South County Galway is recruiting for a planner/buyer to join their team, you…

 

Read More