Regulatory Manager

Catalyst

Regulatory Manager


  Dublin,
Posted
1 month ago
Duration
Contract
Salary
Competitive
Sector
Regulatory Affairs

Apply Now

This opportunity is with a global medical device manufacturer of Haematological IVD devices who are looking for a Regulatory Manager to join their teams. You will be responsible for all RA activities including ensuring submission of global registrations and compliance with international regulations.

Role responsibilities:

  • 5+ years’ experience in the medical device industry.
  • Manage registration requirements of medical devices in global jurisdictions inclusive of to USA and Canada.
  • Oversee product labelling activities to ensure claims meet internal and external standards.
  • Manage regulatory changes communicating with notified authorities for all registration activities.
  • Review and maintain all Risk Management/DHF/Technical Files in accordance with international requirements i.e. FDA QSR, 21CFR820, ISO 13485, FDA QSR, 21CFR820, ISO 13485
  • Experience carrying out Quality Audits.
  • Develop and mentor RA staff as appropriate.

We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.

Hannah.Hughes

Apply Now

Contact

Email
+44 (0) 20 3589 9300
 

Share job

  

Similar Jobs

Not found what you're looking for?