LOCATION:  New York State
SALARY:  105k

Provide Regulatory Affairs management for various projects, to include 510(k), PMA, IDE, label/advertising review, and other regulatory affairs support activities.
Develop Regulatory strategies and timelines for product development and product improvement projects.
Lead and prepare US and non-US product submission projects such as 510(k), PMA, IDE, and CE technical files. This requires participation in product development teams, a well as responsibility to review, analyze, and comment on technical reports.
Review, approve, and provide guidance for labeling and advertising of THE FIRM 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 THE FIRM device products. Participate in industry working groups on advocacy initiatives.

Requirements
•    BA/BS degree in a technical or scientific discipline such as biology, chemistry, physiology, engineering,      medical or law. Advanced degree or additional professional training would be of value.
•    Minimum 5-7 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.
•    10+ years experience in the Medical Device or Drug Industry desired. Knowledge of medical device or            drug GMPs desired

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