| REGULATORY AFFAIRS
– Associate Manager LOCATION: New York State SALARY: 55-75k Provide Regulatory Affairs management for various projects to include 510(k), PMA, IDE, label/advertising review and other regulatory affairs support activities. Prepare US and non-US product submissions such as 510(k), PMA, IDE, CE technical file and product dossiers. Participate in product development teams, as well as, responsibility to review, analyze and comment on technical reports. Review, approve and provide guidance for labeling and advertising of our client's device products. Counsel technical and business groups to establish direction based on available data and regulatory considerations. Provide review and guidance of failure Investigations and corrective actions referred to regulatory Affairs. Provide guidance on regulatory compliance. Review and approve
policies and procedures. Interact with US and non-US government
officials on product approval and compliance issues. Provide input and comment to regulations and standards which may affect our client's device products. REQUIREMENTS: · BA/BS degree in a technical or scientific discipline. · Advance degree or additional professional training is a plus. · Minimum 3-5 years experience in Regulatory Affairs with a demonstrated capability and experience preparing submissions for US Class II/Class III medical devices, as well as, non-US medical device registrations. · 5+years experience in the Medical Device or Drug Industry desired. Knowledge of medical device or drug QSR's desired. · Must have excellent communication, organization, time management and writing skills. Computer literate with general office software and internet use. |
