REGULATORY AFFAIRS SPECIALISTS x 2 required by CareerWise Recruitment for our medical device client at their diagnostics division in Co. Longford. Permanent role and 24 month Fixed Term Contract roles available.
The REGULATORY AFFAIRS SPECIALISTS x 2 will be working on a project relating to the European Union regulation, REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals).
Role of this position
- Provide support for Regulatory Affairs related issues to ensure compliance with global regulatory requirements & Quality System regulations.
- Execute and complete tasks and deliverables for CE marking activities as required according to IVD Directive.
- Prepare and maintain Technical Documentation for Irish manufactured products.
- Provide update and maintain status of product registrations and notifications.
- Provide the required information including legal documentation for country specific Regulatory Affairs contacts to enable and maintain product submissions outside the EU as required.
- Provide, as required, regulatory input and approval for changes and classification of changes to Device Master Records, Quality System records, labelling etc.
- Perform regulatory risk assessments and provide approval for Customer and Quality Technical Communications.
- Conduct business in a manner that will protect human health, safety and the environment by complying with all applicable EHS laws, as well as the Global & Technical Standards.
- Maintain ETMS To Do training list including those standards, Directives, and Regulations defined as relevant.
- You will have a relevant third level qualification to Degree level.
- 2-3years experience in Regulatory, Technical or Quality areas within the devices or pharmaceutical industry.
- Advanced organizational skills and attention to detail.
- The ability to work co-operatively and effectively with others to establish and maintain good working relationships.
- The highest levels of integrity in the successful completion of your work.
- Excellent Communication Skills.
Please call Conor Twomey today for further information on 087-0907204 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)