On behalf of my client, a global medical device company, I am recruiting for a Communications Specialist. In this role you will joint the Regulatory team and you will serve as a communication liaison between the Company manufacturer and the Company local affiliates or regulatory authorities. You will assist in assessing complaints for Regulatory Reporting, this includes Adverse Event Reporting (MDR, Vigilance, etc.), Post Market Surveillance Activities (PMS, PMCF, CER) and associated correspondence to applicable Regulatory bodies.
Applications are invited from candidates with the following background and experience:
- Third level Qualification in Science/Engineering desired.
- A number of years experience in a regulated industry in a similar role required.
- Thorough knowledge of the EU & US medical device regulatory requirements.
- Knowledge of regulatory requirements in MDSAP countries.
- Desirable to have knowledge of requirements in other jurisdictions.
- Knowledge of medical device quality standards/practises or similar regulated industry.
- Good communication and inter-personal skills.
- Proven problem-solving skills.
- Good computer skills including knowledge of Microsoft®
- Proven organisational skills.
- High self-motivation.
- Willingness and availability to travel on company business.
For a full Job Spec and to apply for this position please call me on +353 1 2784671 or e-mail firstname.lastname@example.org.
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671