Description
My Client is a Medical Device company located in New Jersey. They are looking to bring on a Sr. Regulatory Affairs Specialist to come join their group.The Sr. Regulatory Affairs Specialist develops and implements regulatory strategies and guidance based on U.S. and International requirements as defined in FDA Regulations, ISO 13485:2003 Standard, European Medical Device Directives, Canadian Medical Device Regulations, Japanese QMS Ordinance (Ministerial Ordinance No. 169), Australian Therapeutic Goods (Medical Devices) Regulations 2002 (No. 236) and other International Regulations.
Description:
-Responsible for regulatory functions including planning and filing of documentation with domestic and international agencies, compliance with regulations and ensuring customer requirements are met.
-Obtains/generates information to be submitted to regulatory authorities and prepares required regulatory submissions.
-Coordinates and prepares 510(k) Premarket Notifications, IDEs, PMAs, Design Dossiers, Technical Files, and periodic reports, as required.
-Provides regulatory guidance to clinical affairs, product development, marketing and manufacturing groups.
Requirements:
-2-5 years experience in Regulatory Affairs
- Medical Device Experience
-Must have proven ability to prepare and submit documents to FDA, such as 510(k) Premarket Notifications, Investigational Device Exemptions (IDEs), and Premarket Approval Applications, (PMAs), Investigational New Drug (IND), or New Drug Applications (NDA).
If you would like to be considered for this position please send over a copy of your CV.
To find out more about Real please visit www.realstaffing.com