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Church & Dwight Co., Inc. Regulatory Affairs Associate in Princeton, New Jersey

At Church & Dwight, we value talented professionals with a strong desire to make a positive impact in our company. As a rapidly growing organization, we are always seeking passionate and creative individuals whose action-oriented mindset will foster continued growth throughout our leading brands.

Role Summary:

The Regulatory Affairs Specialist will possess and maintain up-to-date knowledge of regulatory requirements relative to products and areas of responsibility as assigned. He/she will be responsible for electronic reporting and registration activities and to provide support for regulatory submission activities.

Responsibilities:

  • Develops and maintains knowledge of products and regulatory requirements affecting products.

  • Tracks and maintains facility registrations and required licenses.

  • Prepares and submits necessary reports for Medical Device Reporting, Serious Adverse Event Reporting and CPSC notifications.

  • Prepares California Mill Tax volumes of sale for reporting purposes and prepares CARB submissions.

  • Processes check requests for Pesticide Registrations, GDUFA fees, and 510(k) fees.

  • Interacts cooperatively and effectively with senior regulatory personnel, as well as coworkers within the company to assist with the preparation of regulatory documents, review of labeling, and collection of data.

  • Manage the Unique Device Identifier (UDI) system for medical devices

  • Maintains Regulatory files, including 510(k) archival, claims support, and product history documents within the scope of record retention requirements.

  • Acts in concert with the company and departmental policies, positions and strategies, adapts well and promptly to changing priorities.

  • Provides periodic reports to keep the senior manager and/or director informed of activities and status of projects.

  • Provides assistance to the team as required.

Requirements:

  • Bachelor’s degree from an accredited institution along with relevant experience

  • Associate's degree and two years of applicable experience in a position within a Quality/Legal/Regulatory group may be substituted

Church & Dwight is proud to be an Equal Opportunity Employer/Veterans/Individuals with Disabilities.

For more information on our company, our brands and our culture visit us at http://www.churchdwight.com/.

• Innovation-We consistently generate new ideas, thinking outside the box while remaining strategically focused. We always think in terms of possibilities, not limitations.

• Collaboration-We rely on open and honest communication to develop productive working relationships within and across our business units and functions. The mutual respect we have for our colleagues enables us to challenge each other, leading to an even more cohesive team.

• Focus-We maintain a laser-like focus on our consumers. We will grow by leveraging consumer insights on all of our brands and will continue to be industry leaders.

• Entrepreneurialism-We pride ourselves on fostering this spirit where risk-taking and action is encouraged. We are extremely competitive externally, but not internally.

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