A Regulatory Affairs Specialist is required by Careerwise Recruitment to work for our Galway based medical device manufacturing client on a 6 month contract.
Role of this position
- Sufficient technical expertise to understand regulatory impact re. safety and efficacy of proposed manufacturing changes
- Monitoring of regulatory changes for impact to site quality system
- Participate in site internal compliance program
- Preparation for external audits
- Provides ongoing input to value improvement engineering teams on possible regulatory impact of proposed changes.
- Applies FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization
- Bachelor's Degree (4 year university degree) life sciences, technical (engineering), quality or related field.
- 3 years' experience in a regulatory position. Regulatory background should include the medical device area.
Please call Michael O'Connor today for further information on 091-452410 or email firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)