We expect the Manager, Regulatory Affairs CMC to join a growing team and provide support to interpret the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process. May act as a submission compliance liaison with other areas of Regulatory A...
Regulatory Manager, Regulatory Affairs - CMC (Gene Therapy). Plans and prepares CMC regulatory packages, assesses changes for potential regulatory impact, responds to action letters, and maintains filings and approvals. Acts as CMC regulatory lead or deputy for complex projects/products, requiring a...
Senior Manager of Regulatory Affairs and Quality Assurance - (Medical Device) - Hybrid in MA. Our client is a growing boutique IVD and Medical Device company and they are seeking a Senior Manager of Regulatory Affairs and Quality Assurance to lead a small international team to ensure compliance with...
Regulatory Manager, Regulatory Affairs - CMC (Gene Therapy). Plans and prepares CMC regulatory packages, assesses changes for potential regulatory impact, responds to action letters, and maintains filings and approvals. Acts as CMC regulatory lead or deputy for complex projects/products, requiring a...
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. Title: Regulatory Affairs Manager. The Regulatory Affairs Manager will be re...
Regulatory Manager, Regulatory Affairs - CMC (Gene Therapy). Plans and prepares CMC regulatory packages, assesses changes for potential regulatory impact, responds to action letters, and maintains filings and approvals. Acts as CMC regulatory lead or deputy for complex projects/products, requiring a...
The newly founded LGBTQ Health Center of Excellence seeks a highly motivated individual to join the organization in the Senior Program Manager role to serve as the Executive Director. From academic faculty and trainees to research/program staff and administrative professionals, no matter the positio...
The Director of Quality Assurance and Regulatory Affairs (QA/RA) is responsible for ensuring that Precision Optics Corporation's products meet applicable regulatory requirements and quality standards. Responsible for all quality assurance and regulatory functions across POC's Portland & Gardner site...
Tracks and reports on status of all project deliverables per the approved project schedule. Plans and executes one or more simultaneous project(s) from initiation through delivery. Organizes cross-functional activities, ensuring completion of the project while adhering to budget, scope and schedule ...
Under the general direction of the Principal Investigator or designee, the Research Program Manager I is responsible for managing the day-to-day operations of NIH or other externally funded, large scale projects. The Research Program Manager will collaborate with investigators, consultants, project ...
Conducts reviews on products/programs to anticipate and identify issues, develop corrective actions, and communicate issues, impacts and corrective actions to program teams. Responsible for managing and driving key performance indicators of cost, schedule and technical performance of a complex techn...
In this role, you will work in collaboration with other talented engineers and project managers to provide professional assistance on complex fire and life safety issues through code consulting, fire protection design, and fire & life safety special inspections and testing services for designers...
Provides technical oversight and coordination of project engineering work; through project coordination meetings and other means, monitors progress against project schedules and budgets; reviews project design for compliance with engineering principles, company standards, contract requirements, and ...
Compliance and Credentialing Manager. The Compliance and Credentialing Manager is a hybrid position based out of our Resource Center in Hopkinton, MA. Advise executives within the company and work alongside employees and departments to develop a company-wide culture of compliance. Manage all day-to-...
The Program Manager is an exciting role that oversees one of the Behavioral Health Community Partners within a consortium. The ideal candidate will enjoy partnership with a other providers in the community as well as with other service programs within Spectrum to ensure all eligible people have the ...
Press Tab to Move to Skip to Content LinkSelect how often (in days) to receive an alert: Create AlertPrincipal Regulatory Affairs Specialist - Endoscopy Onsite Location(s): Marlborough, MA, US, 01752Additional Locations: N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - Hi...
The Principal, Global Compliance Audit & Monitoring position reports directly to the Associate Director, Global Compliance Audit & Monitoring and is responsible for supporting program/project planning, execution, implementation, and reporting across a variety of Global Compliance programs. Obtain an...
Principal Regulatory Affairs Specialist - EndoscopyAbout the role:At Boston Scientific, this is a place where you can find meaningful purpose, improving lives through your life's work. This role in Regulatory Affairs will be responsible for developing regulatory strategies and support for new busine...
Regulatory Affairs Leader (Associate Director). Bachelor's Degree (or internationally recognized equivalent) & minimum of 3 years experience in the pharmaceutical or biotechnology industry or with regulatory agencies; OR minimum of 7 years progressive regulatory affairs experience. The Regulator...
Senior Director of Quality, Regulatory and Clinical Affairs. The role will be responsible to work through multiple levels within the organization and external stakeholders to influence and drive Waters Quality, Regulatory & Clinical Affairs strategy to support Waters business growth and success ...
The HR Compliance Manager is responsible for developing, implementing, and managing a comprehensive compliance program to ensure adherence to federal, state, and local regulations. Develop and update compliance policies, guidelines, and training programs to educate employees on compliance requiremen...
The Specialist, I - Regulatory Affairs will support the maintenance of EU MDR technical documentation and conduct other elements of sustaining Regulatory Affairs including maintaining “state of the art”. In addition, this position will support the regulatory department by maintaining data within reg...
CRJ wants you to join our growing team of compassionate and dependable Program Managers to support the wonderful individuals we serve!. Ensure that personal, medical and nursing care, behavior plans, teaching programs and other services are delivered by program staff in an appropriate and consistent...
The Engineering Program Manager will be responsible for multiple Programs, and Programs may consist of single or multiple Projects within the Program, largely dependent upon size and complexity. The Engineering Program Manager is accountable for the overall program success through the full customer ...
Splunk is looking for a motivated Senior Analyst who is passionate about delivering technology assurance, advisory, compliance and risk management services to the company. You will ensure proper identification and mitigation of risks / processes / internal control gaps that have potential operationa...