A Principal Regulatory Affairs Specialist is required by CareerWise Recruitment for our Shannon or Galway based client.
Responsible for managing all facets of regulatory support, this includes developing regulatory submissions, managing departmental projects, requesting and reviewing site specific labelling, and providing guidance and consultation for domestic and international regulations, interacting with governmental agencies.
Role of this position
- Management of the RA function for all manufacturing transfers, manufacturing process changes, introduction of new critical vendors and new product introductions.
- Prepares/Reviews product registration for OUS countries to support the Demand Plan.
- Prepares/Reviews Change Notifications to the EU design dossier for EU Class III products.
- Updates/Maintains of EU Technical Files for EU Class IIb as part of the CE Marking process.
- Regulatory approval of labelling for product transfers or new product introduction in accordance with relevant labelling requirement.
- Management of all Regulatory assessments including managing field notifications in relation to the modification to existing products and introduction of new products using relevant guidance documents.
- Bachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred.
- 6-8 years of experience in Regulatory Affairs, including preparation of submissions to the FDA/EU.
- A minimum of 3 years of experience in medical device, drugs, biologics, and/or combination products, preferred.
- Regulatory Affairs Certification (US or EU) preferred.
Please call Lisa Casserly today for further information on 091-339136 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)