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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 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 & CompanyRegulatory Affairs Professionals Society
Boston, MA, United States
Job Summary The mission of the Harvard T.H. Chan School of Public Health is to advance the public's health through learning, discovery and communication. To pursue the mission, the school produces knowledge through research then translates this knowledge into evidence that can be communicated to the public, policymakers, and practitioners to advanc
Job Source: Regulatory Affairs Professionals SocietyGabriele & 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 & CompanyBioTalent Ltd
Norwood, MA, United States
Summary: The Regulatory Affairs Manager is responsible for overseeing all regulatory activities within Advanced Instruments. This includes developing and implementing regulatory strategies for product approvals, leading the registration of products, ensuring compliance with global regulatory requirements, and managing the regulatory affairs team. T
Job Source: BioTalent LtdCatalyst 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 DiagnosticsX4 Life Sciences
Chelmsford, MA, United States
A small-scale medical device organization based in Chelmsford, MA that focus on plastic injection molding has focused their efforts on brining in a Manager of QARA on a full-time basis. This individual is expected to come in and lead the entire QARA team, incorporating responsibility for activities in which the company will uphold it's regulatory c
Job Source: X4 Life SciencesWaltham, 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 techniques, including MXIF, IHC, Flow cytometry, and DNA and RNA sequencing (exome).
Responsibilities
Develop and implement regulatory strategies and processes to ensure compliance with ISO standards and Good Laboratory Practice (GLP) requirements.
Provide strategic and tactical regulatory guidance to influence project planning and decision-making processes positively.
Develop clinical and commercial regulatory strategies for assigned products to facilitate successful study designs and timely registration with regulatory health authorities.
Collaborate with internal teams and diagnostic partners to align on co-development regulatory needs and expectations, including regulatory submissions (e.g., PMA, 510(k), IDE).
Prepare for and facilitate meetings with regulatory agencies in collaboration with diagnostic partners and internal teams.
Review and approve key diagnostic regulatory submissions to CDRH and global health authorities, as agreed upon with diagnostic partners.
Interact with international regulatory colleagues and diagnostic partners to determine best practices and regulatory paths for development and global registration activities.
Assess the impact of relevant regulations on drug and diagnostic development and registration activities.
Provide regulatory support for due diligence activities related to external diagnostic companies.
Qualifications
PhD and/or MS degree preferred within Regulatory Affairs, Life Sciences, or Engineering.
6 plus years of experience in Regulatory Affairs, including United States and international medical device and/or IVD/CDx regulations.
8 plus years of experience in medical device and/or IVD/CDx industry.
Proven experience in effectively communicating and working with US FDA, Competent Authorities, and other regulatory agencies.
Regulatory submissions experience.
Must be detail-oriented, well-organized, and able to work both independently and in teams.
Exceptional written and strong verbal communication skills.
About BOSTONGENE
BostonGene Corporation is pioneering the use of biomedical software for advanced patient analysis and personalized therapy decision-making in the fight against cancer. BostonGene’s unique solution performs sophisticated analytics to aid clinicians in evaluating viable treatment options for each patient’s individual genetics, tumor and tumor microenvironment, clinical characteristics, and disease profile. BostonGene’s mission is to enable physicians to provide every patient with the highest probability of survival through optimal cancer treatments using advanced, personalized therapies via sophisticated analytics and the integration of scientific and clinical knowledge.
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Email Alert for Regulatory Manager jobs in Waltham, MA, United States
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