Email Alert for
ⓘ There was an unexpected error processing your request.
Please refresh the page and try again.
If the problem persists, please contact us with your issue.
You can always manage your preferences and update your interests to ensure you receive the most relevant opportunities.
Get ready to discover your next great opportunity.
Home 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 FoodsHome 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 FoodsBostonGene
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 & CompanyHiring Now!
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 to the regulatory approval process (including US FDA and other regulatory authorities) for FMI products. The incumbent functions as the regulatory representative on cross-fu
Job Source: Hiring Now!Gabriele & Company
Boston, 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 hos
Job Source: Gabriele & CompanyCatalyst Life Sciences
Canton, MA, United States
Opportunity to join a global medical instrumentation organization as they grow the regulatory team due to successful acquisitions and increases to their product portfolio. Focusing on existing products, you'll have global reach on ensuring they remain compliant with US, EU IVDR, and global regulations. Responsibilities: Lead and coordinate the tran
Job Source: Catalyst Life SciencesGenabio Diagnostics
Bedford, MA, United States
Qualifications : degree or above in a relevant discipline required years of industrial experience in IVD or medical device FDA registration in Chinese preferred Tasks: and support new product 510k Submissions and support International Device Licensing and Registrations product development teams with new product submission requirements guidance on w
Job Source: Genabio DiagnosticsBoston, 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 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:
Bachelors 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!
Email Alert for Regulatory Manager jobs in Boston, MA, United States
ⓘ There was an unexpected error processing your request.
Please refresh the page and try again.
If the problem persists, please contact us with your issue.
You can always manage your preferences and update your interests to ensure you receive the most relevant opportunities.
Get ready to discover your next great opportunity.