Regulatory Affairs Associate

Location: Mahwah
Posted on: May 5, 2024

Job Description:

Regulatory Affairs Specialist

BA/BS in Scientific discipline required. Engineering strongly preferred

RAC certification desired

Responsibilities:

Ensure compliance to all internal, US, EU and other international requirements and corporate policies and procedures for market approval of medical devices/combination products.

Apply scientific principles to understanding safety and efficacy on a wide range of products.

Prepare documentation for international submissions and ensure that existing approvals and documentation are maintained. Communicate with in-country RA personnel to facilitate global clearances/approvals.

Manage and implement data for UDI compliance for all divisional product lines.

Prepare Certificates to Foreign Government, organize and maintain RA files.

Reviews and approve labeling (Instructions for Use, labels, promotional materials) for compliance to: standards, guidelines, regulations, and regulatory approvals/clearances.

Performs responsibilities required by the Quality System and other duties as assigned or requested.

Uses existing project management tools, and develops/implements new tools as needed.

Regulatory Affairs Experience:

510(k), IDE, PMA (original/revision/supplements) preparation

Minimum 2 years experience in FDA regulated industry

Working knowledge of Medical Device Regulations (FDA required, international a plus)

Must be able to multi-task and prioritize

Strong communication skills and organizational skills are essential.

Proficiency with MS Office required, strong MS Excel knowledge

Keywords: , Greenwich , Regulatory Affairs Associate, Healthcare , Mahwah, Connecticut