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Tandym Group
Woburn, MA, United States
Our client, a leader in the pharmaceutical industry, is seeking a Regulatory Project Manager to join their team. In this role, the Regulatory Project Manager will be responsible for supporting the execution of regulatory strategies within the Global Regulatory Affairs function with specific focus on regulatory filing activities, project management
Job Source: Tandym GroupHome Market Foods
Norwood, MA, United States
Due to our rapid growth, our success is directly dependent on attracting and retaining the best possible talent across our teams. To this end, we are posting for a strong Regulatory Manager that specializes in UDSA Regulations. OVERVIEW OF ROLE: The Regulatory Manager oversees all aspects of USDA Regulatory compliance. They will be a strategic le
Job Source: Home Market FoodsGabriele & Company
Boston, MA, United States
Job Title: Medical Devices Regulatory 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 Manager to d
Job Source: Gabriele & CompanyBostonGene
Waltham, MA, United States
Position Summary BostonGene is seeking a Regulatory Manager to join our team and play a crucial role in supporting our ISO certification efforts and regulatory compliance. The primary focus of this position will be on ensuring Good Laboratory Practice (GLP) and ISO conversion for a team dedicated to assisting cancer patients using various molecular
Job Source: BostonGeneGabriele & Company
Boston, MA, United States
Job Title: Medical Devices Regulatory 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 Manager to d
Job Source: Gabriele & CompanyHome Market Foods
Norwood, MA, United States
Due to our rapid growth, our success is directly dependent on attracting and retaining the best possible talent across our teams. To this end, we are posting for a strong Regulatory Manager that specializes in UDSA Regulations. OVERVIEW OF ROLE: The Regulatory Manager oversees all aspects of USDA Regulatory compliance. They will be a strategic le
Job Source: Home Market FoodsThe Judge Group
Boston, MA, United States
About the Job The Manager, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval process (including US FDA and other regulatory authorities) for FMI products. The incumbent functions as the regulatory representative on cross-funct
Job Source: The Judge GroupDeciphera Pharmaceuticals
Watertown, MA, United States
Company Description Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.
Job Source: Deciphera PharmaceuticalsBoston, MA, United States
Job Title: Regulatory Project Manager
Increase your chances of reaching the interview stage by reading the complete job description and applying promptly.
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!
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Email Alert for Regulatory Project Manager jobs in Boston, MA, United States
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