Principal Regulatory Affairs Specialist - Endoscopy. This role in Regulatory Affairs will be responsible for developing regulatory strategies and support for new business development efforts associated with external manufacturers (OEM) and contract manufacturers. Responsible for preparation and subm...
Principal Regulatory Affairs Specialist - Endoscopy. Principal Regulatory Affairs Specialist – Endoscopy . This role in Regulatory Affairs will be responsible fordeveloping regulatory strategies and support for new business development efforts associated with external manufacturers (OEM) and contrac...
Our client is currently seeking a Senior Regulatory Compliance Specialist. Monitor international standards and guide regulatory testing requirements. Assist with risk analysis and regulatory submissions. ...
The Regulatory Affairs Specialist will work closely with the Director of Regulatory Affairs to obtain and maintain global regulatory approvals to allow IPG to market its state of the art devices worldwide. The ideal candidate is a diligent, hardworking individual with 2 to 5 years of regulatory expe...
In addition, this position will support the regulatory department by maintaining data within regulatory data systems, supporting regulatory projects and initiatives and by supporting ongoing regulatory operations. The Specialist, I - Regulatory Affairs will support the maintenance of EU MDR technica...
In addition, this position will support the regulatory department by maintaining data within regulatory data systems, supporting regulatory projects and initiatives and by supporting ongoing regulatory operations. The Specialist, I - Regulatory Affairs will support the maintenance of EU MDR technica...
Principal Regulatory Affairs Specialist – Endoscopy . This role in Regulatory Affairs will be responsible for developing regulatory strategies and support for new business development efforts associated with external manufacturers (OEM) and contract manufacturers. Responsible for preparation and sub...
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...
They will work closely with the Project Executive, Project Sponsor, and Project Management Team to define the project objectives, create the project plan and execute the plan to achieve those objectives. The Project Manager must be an excellent communicator at all levels within the project environme...
As part of a team-based approach to care, the Clinical Care Manager (CCM) provides, coordinates, and organizes evidence-based care management to Medical Assistant Treatment Program (MAT) patients. We are currently hiring a Clinical Care Manager – OBAT RN based in Framingham. Responsible for as...
As the Associate Director of Regulatory CMC, reporting to the Director of Regulatory CMC, you will be pivotal in managing the development and submission of regulatory filings for gene therapy projects both domestically and internationally. Identify and articulate regulatory opportunities and challen...
Provide overall company leadership and direction for worldwide Tecomet Quality Assurance and Regulatory Affairs Systems, encompassing both improvements and sustaining activities. ...
Participate as a regulatory representative in relevant teams, advising on regulatory strategies, submission preparation timelines, processes, and requirements. Monitor and evaluate the US regulatory affairs environment to maintain awareness of current and future risks that may impact the business. C...
Analyze and review test packets, creating detailed test logs to track quality assurance. Oversee multiple projects concurrently, ensuring that quality standards are consistently achieved. Address quality issues promptly and develop effective solutions. Create or update procedures for capturing, inve...
Are you a seasoned regulatory CMC leader looking for a new challenge? We are seeking a dynamic professional to lead a Global Regulatory Affairs CMC team in a top-tier biopharmaceutical company. This is a pivotal role that will shape global CMC regulatory strategies through all phases of product deve...
We seeking a highly collaborative, proactive Customs & Trade Compliance Analyst to ensure our adherence to U. Manage and conduct import and export compliance audits, review corrective actions, evaluate broker/freight forwarder compliance and report monthly metrics. Identify and report to Bose Corpor...
Senior Analyst to join our Compliance team! This is an exciting new opportunity for an individual to join a growing company and compliance team. Senior Analyst, Legal & Compliance. Act as a primary legal and compliance resource for business units, offering timely and accurate legal research and ...
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...
Program Manager Pilot Production**. Systems Marlborough, Massachusetts Minimum Experience **Experienced** Ambri, an energy startup commercializing an innovative battery technology first developed at MIT, is seeking a Program Manager that will provide expertise in new product introduction in s...
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 successful candidate will foster compliance across a broad range of Quality Assurance areas and will work closely with counterparts in the Manufacturing, Quality Control, and Materials Management teams to help ensure high quality standards and value delivery for our patients. Senior Validation S...
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 Department consists of six main functional areas: Loan Administration, Asset Management, Insurance Compliance, Investor Reporting, Treasury, and Compliance. This position is a key member of the Servicing department working with the senior members of the Compliance team responsible for developmen...
Senior Compliance Risk Analyst. This role will support the overall privacy team and compliance initiatives by providing in-depth analysis, research, and coordination of projects, as assigned. Collaborates with various departments including IT, Risk Assurance and Marketing to ensure website processin...
Leverage your expertise in project management, leadership, and team building to confidently lead implementation teams, ensuring high-quality deliverables. Mitigate risks and estimate project budgets accurately, demonstrating a commitment to client satisfaction. Advocate for process improvement and p...