Regulatory Project Manager

Job Title: Regulatory Project Manager

Gabriele & Company, recruiters for manufacturing and supply chain professionals, is assisting a globally renowned, small medical device company whose products are used in nearly half of all hospitals in the US. This world leader in their market niche is seeking an exceptional Regulatory Project Manager to drive new product line initiatives.

Reporting to the VP, you will spearhead the management of new product line(s). In this pivotal role, you will collaborate cross-functionally to ensure products seamlessly align with technical, regulatory, clinical, and market standards.

Salary Range: $120,000 - $150,000 per year, commensurate with experience, along with a generous benefits package.

Key Responsibilities:

Create and manage comprehensive product/project databases

Develop and execute strategic product line release plan(s)

Work closely with Regulatory lead/Quality team, keeping stakeholders updated

Liaise across departments for regulatory documentation (domestic & international)

Manage clinical/non-clinical stakeholders for product release readiness

Maintain, improve and update all relevant regulatory documentation/best practices

Participate in CAPA Review Board, recommending corrective actions

Assist with regulatory information management system, QMSR processes, new eQMS

Requirements:

Bachelor's degree

7+ years of Quality/Regulatory Affairs experience in Medical Device industry

Regulatory Affairs knowledge

Quality Management system knowledge

510K submissions

Clinical submissions and trials

MDR (Medical Device Rugulation/Reporting)

ISO

EU requirements

MDSAP (Medical Device Single Audit Program)

Auditing experience

Please apply or reach out if interested in this Quality and Regulatory Project Manager opportunity with a global medical device leader!