- 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
- 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
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Quality Regulatory Manager - Boston, United States - Gabriele & Company
Description
Job Title: Quality and 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 Quality and 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:
Requirements:
Bachelor's degree
Please apply or reach out if interested in this Quality and Regulatory Project Manager opportunity with a global medical device leader