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Genabio 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 DiagnosticsBioTalent
Norwood, MA, United States
Introduction BioTalent is representing a top-tier life sciences device manufacturer hiring a Regulatory Affairs Manager ensure compliance with global regulatory requirements while managing the regulatory affairs team. The role requires collaboration with product development, quality assurance, and other cross-functional teams to support the organiz
Job Source: BioTalentCatalyst 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 SciencesHiring 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!Foundation Medicine
Boston, MA, United States
Job Description 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 representat
Job Source: Foundation MedicineBioTalent 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 LtdOxenham Group
Watertown, MA, United States
QUALIFICATIONS: - BS or MS in a scientific discipline with 7-10 years of direct experience in Quality Assurance and Regulatory Affairs within the Medical Device industry - Strong knowledge of FDA and global regulatory requirements (EU/UK Regulations, ICH Guidelines, Common Rule, 21 CFR 56, 45 CFR 46; ISO 13485, 21 CFR 820, 21 CFR Part 10, 21 CFR Pa
Job Source: Oxenham GroupThe 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 GroupBoston, 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-functional teams as well as prepares and submits packages to the FDA for approval of new products or new companion diagnostic indications. The position actively supports the development of regulatory strategy focused on the use of NGS technology for companion diagnostic assays for cancer patients. Additionally, this position partners closely with product development teams and external partners focused on development of genomic biomarkers and companion diagnostic indications.
Key Responsibilities
Manage pre-market submissions for regulatory approval of in vitro companion diagnostic medical devices in the US market.
Develop regulatory strategy with oversight for complex projects, including internal FMI projects as well as biopharma partner projects.
Develop and implement regulatory strategy for non-clinical product development and clinical development.
Provide regulatory support for currently marketed products, e.g., review engineering changes, labeling, promotional material, product change control documentation to ensure compliance with federal regulations and health authority guidance, including for changes requiring regulatory agency approval or notification, as pertains to US regulatory requirements.
Represent FMI in interactions with external partners for companion diagnostic development or support for partner drug filings.
Review and edit technical documents to be included in submission, which may include validation protocols and reports and/or other development documentation.
Author regulatory submission documentation, including SRDs, IDEs, and PMAs.
Ensure that software and data products are developed and validated to standards required for FDA-regulated products and/or for data included as part of a drug or diagnostic regulatory submission (e.g. SRDs, IDEs, Pre-Submissions, PMA).
Acquire and maintain current knowledge of applicable regulatory requirements, scientific and technical issues in the discipline as relevant to assigned projects.
Interpret and apply FDA regulations and guidance documents to business practices, evaluating risk and proposing solutions to business challenges based on regulatory strategy.
Interface with regulatory authorities on regulatory and technical matters as directed, including lead meetings with the regulatory authorities.
Manage and mentor junior members of the Regulatory Affairs Team.
Represent Regulatory Affairs department at cross-functional internal project meetings.
May perform other duties as required or assigned.
Qualifications:
Basic Qualifications:
Bachelor’s Degree and 4+ years of experience in life sciences, biopharmaceutical, medical device, biologics regulatory or closely related field, OR
Advanced Degree (Master’s or Doctorate Degree) in science, law, health policy, regulatory affairs or engineering and 2+ years of experience in life sciences, biopharmaceutical, medical device, biologics regulatory or closely related field
Experience in regulatory affairs
Preferred Qualifications:
2+ years of experience in regulatory affairs within the life sciences industry
Experience:
interpreting and applying FDA guidance and regulations
interfacing with the FDA (e.g., CDRH), including submissions (e.g., SRDs, IDEs, PMAs) and with pre-submission meetings
preparing and managing IDE and PMA submissions
with genomic data analysis, especially in a regulated environment
Industry experience in oncology, NGS, IVD, CDx, CAP/CLIA, and/or regulatory
Understanding of the principles of scientific, engineering, physiology and medical device use
History of effective time management, organization, prioritization and multitasking
History of proactive and independent problem solving
Strong collaborative skill set, demonstrated by creative and effective contributions in cross-functional or cross-departmental partnerships
Demonstrated organization, attention to detail and high level of accuracy
Effective and clear oral and written communication skills, and negotiation skills
Demonstrated ability to:
prepare and present information to groups
interact effectively across relevant functions
manage multiple activities or projects
work in a fast-paced/entrepreneurial environment
Understanding of HIPAA and the importance of patient data privacy
Commitment to reflect FMI’s values: Patients, Passion, Innovation, and Collaboration
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Email Alert for Manager, Regulatory Affairs jobs in Boston, MA, United States
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