Description
I have an immediate opening for a Clincal/Regulatory Affairs Specialist with a rapidly growing medical device start up company based in Galway. This really is an excellent opportunity to join the company at a really exciting stage in their growth and development.Roles and Responsibilities:
- Generate Clinical Literature reviews to support regulatory filings or engineering specifications
- Complete biological safety evaluations
- Participate in Clinical studies and co-ordinate with CROs
- Co-ordinate animal studies and evaluate and interpret results
- Assist with regulatory submissions and product registrations
- Document Regulatory Notes to files for product and change requests
- Maintain technical documents that provide the basis for Design History Files
- Specify necessary design input requirements for devices being developed
- Implement Quality Systems updates for new Regulatory Requirements
- Complete Risk Management and Post Market Surveillance activities
- Support and participate in R&D, design control and Quality and Regulatory activities as deemed necessary by the QA/RA Director
Education Requirements:
- A degree in engineering or science
Skill Requirements:
- Strong written and verbal communication skills
- Project planning
- Meticulous documentation and record-keeping skills
Experience Requirements:
- A minimum of 2 years experience in a design or manufacturing environment including post graduate studies if relevant
This is an excellent opportunity to join an innovative and highly ambitious medical device company in Galway. If you feel you are a good fit please apply directly to this advert or contact Derek Sheridan on .