REGULATORY AFFAIRS ASSOCIATE
Our client, alarge health care company is looking for a Regulatory Affairs Associate to join their team on a permanent basis. This position is located in the Munster region.
- Strategy development for regulatory approval of medical devices
- Coordinate submission for regulatory approvals; clinical trials, pre-market approval
- Consult internally on issues such as recalls, advertising or review of device changes
- Develop and deliver presentations to regulatory agencies,
- Research regulatory requirements for assigned geographies.
- Participate in training and mentoring of staff
- Coordinate IFU development activities
- Participate in department systems development initiatives
Key Requirements :
- A minimum of 6+ years experience working in regulatory affairs in a necessity
- Bachelors degree
- Advanced degree is preferred but not necessary
- A solid understanding of business concepts, procedures and practices are key requirements.
- Problem solving ability
- Strong leadership is a must
- The ideal candidate will be extremely Organised and attention to detail are vital for this position
- Decision maker skills are necessary
This opportunity offers candidates the chance to work in a very dynamic company. If you are interested and feel you have the desired qualification apply to Jennifer Dawson at Sigmar Recruitment. Jennifer can be contacted at 01-4744636 in relation to the role.