Regulatory Affairs Specialist

Responsible for the preparation of regulatory submissions required to market new or modified medical devices and in vitro diagnostic devices in both domestic and international clinical markets.

Understands and interprets U.S. and international medical device and in vitro diagnostic device (IVD) regulatory requirements

Prepares U.S. regulatory submissions necessary for new product market clearance/approval and product continuance: 510(k)s; Pre-market Approval Applications (PMA) and supplements; Investigational Device Exemptions (IDE).
Prepares and/or compiles information required by ex-U.S. regulatory associates to register or license products outside the U.S.
Interacts and negotiates with U.S. regulatory agencies.

General requirements :
B.S. degree in the biological sciences, chemistry or related science required.
Minimum of 3 years experience in the device/diagnostic, biologic and/or pharmaceutical industry, primarily in the area of regulatory affairs or working with molecular instrumented products.
Current knowledge of U.S. medical device and in vitro diagnostic regulatory requirements, Good Laboratory Practices (GLP) and Quality System Regulations (QSR); current knowledge of European Medical Device and IVD Directive requirements and European quality system standards. Knowledge of Canadian and Japanese device regulations desired

Candidates should have some experinence with :
3 years experience in the device/diagnostic, biologic and/or pharmaceutical industry, primarily in the area of regulatory affairs or working with molecular instrumented products.