Regulatory Affairs Specialist Job Princeton area,New Jersey USA,Healthcare

The essential job duties and responsibilities include, but are not limited to the following:

Responsibilities

Utilize the Regulatory Information Management System (RIMS) to manage data accuracy, integrity, and process efficiency; perform data analysis and manage submission/document and data uploads and verification; generate RIMS extracted reports to support regulatory strategies, key performance indicators, and blocked orders, etc.

Develop, maintain, monitor and continuously improve regulatory global standard operating procedures (GSOPs), work instructions, and process controls to support organizational compliance.

Collaborate and provide cross‑functional expertise and support for regulatory operations department requirements such as device establishment registrations, device listings, global unique device identification (UDI) (e.g., FDA GUDID, EUDAMED, AUSUID, etc.) and electronic publishing.

Utilize knowledge of all applicable laws and regulations that apply to the industry, and assure staff members are aware of the legal standards that apply to their work and that they are followed. Review the processes used in the industry, establish guidelines and standards for specific tasks, evaluate the processes in place, and review data and documents. Bachelor’s Degree is required.

4‑6 years of experience.

Support the development and execution of regulatory strategies with a strong focus on global compliance. Manage Regulatory Operations activities by ensuring regulatory readiness, operational efficiency, and timely market access by maintaining accurate regulatory data in RIMS, scalable global processes, and inspection‑ready documentation across multiple jurisdictions. Also support cross‑functional areas such as regulatory intelligence, UDI, publishing, and establishment registrations.

Qualifications

Prior experience with authoring and executing standard operating procedures, process documentation and automation.
Prior experience with regulatory data governance platforms and change management systems (e.g., Veeva Vault, Agile, etc.).
Exposure to process automation, dashboards, or analytics (Power BI, Tableau, etc.).
Familiarity with regulatory submission formats, including eStar, eCTD, and paper submissions.
Must possess and demonstrate an understanding of FDA Regulations and international regulations.

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”

Please feel free to call me on 732‑806‑7467 or send me an email at If you are inclined, I would be happy to set up some time to chat more about your background and career interests to see if there could be a possible match.

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