Description
My Client a global medical device company is currently seeking Regulatory Affairs Manager to join their team on temporary basis.The primary function of this role is to supervise the Regulatory Affairs area to ensure that it runs in a smooth and efficient manner. Function will involve a thorough understanding of the regulatory requirements required for the Medical Device Industry.
Responsibilities:
- Supervising the day to day workload and operational issues of the regulatory affairs team.
- Monitors the progress of RA team members on assigned tasks, and removes roadblocks.
- Mentor and train new RA team members Highlight any updates to regulatory requirements to Senior Management Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as needed or collaborates with their assigned regulatory specialists on same.
- Review submissions generated for their assigned regulatory area to ensure compliance to the regulations in that particular jurisdiction.
- Maintain a system for registration information (license numbers, expiration dates etc) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability
Requirements:
- Third level Qualification in Science/Quality
- 5 years experience in a regulated industry in a similar role
- Thorough knowledge of the FDA requirements with regard to Clinical Trials and 510K and PMA submissions
If you are interested in this great opportunity and have the relevant skill set and experience please contact me Anna Mooney or apply below with an up to date CV
To find out more about Real please visit www.realstaffing.com