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  Work Description Manages all regulatory interactions with local health authorities in the US and Canada. Provides input into the development of regional RA strategies- Central contact point for all Novartis Vaccines regulatory interactions with the respective local Health Authorities- Monitors local guidelines and vaccine specific recommendations- Prepares and/or comments on draft documentation sent out for consultation from the health authority- Input to Regulatory Operations of local ...

Responsibilities: • Responsible for input including: documentation, application forms, regulatory submissions (briefing documents/INDs/BLA's/Post Marketing submissions, etc.) • Prepares and reviews local labels. In consultation with Sr. Managers, contributes to regulatory interactions with local health authorities in the US and Canada. • Provides input into the development of regional RA strategies. • Contact point for all regulatory interactions with the respective local Health Authorities. ...

 Summary of Position The Health Care Economics Senior Specialist (HCES) is responsible for developing, implementing, and managing global economic and statistical outcomes research plans for a defined portfolio of medical device products within the major Medical Device Global Business Units (i.e. Surgical Solutions, Vascular Therapies and Respiratory/Monitoring Solutions).  The position also does analyses to support business development initiatives and programs across company.  The HCES will assist in ...

Manager, Regulatory Affairs Cambridge, MA Contract: 12 month renewable    Position Summary:   Serves as a liaison between the company and regulatory agencies for all assigned projects and is responsible for day to day regulatory support. Expected to provide guidance within Regulatory Affairs and to data generating departments to ensure timely filing and approval/maintenance of assigned programs.  Duties and Responsibilities:  • Responsible for representing Regulatory on clinical trial working group ...

Associate Director, Regulatory Affairs Cambridge, MA Contract: 12 months renewable     Position Summary: This individual is expected to provide leadership within the Regulatory Affairs Labeling group and will be responsible for actively contributing to the development and implementation of regulatory labeling strategy and documentation for marketed products and products in development. This person will serve as the Regulatory Labeling representative on relevant project teams.   Duties and ...

 My name is Myesha Oliver and I represent The Fountain Group.  We are a national staffing firm and are currently seeking Mgr Quality Assurance for a prominent client of ours.  This position is located in Lexington, MA. Details for the positions are as follows:   Job Duties: Job Description:   Primary Role: This individual will work in the Quality Assurance department as part of External US QA. This individual will provide QA support of expansion into global supply of commercial Diagnostic Kits, ...

Our client is looking for a project manager with IT regulatory experience in the biotech industry. The position is located in cambridge, MA. Project Manager – Regulatory IT Job Summary: The INSIGHT Project Manager is responsible for the planning and execution of business process improvement and regulatory information management project. The INSIGHT Project Manager will work with business process owners, information technology staff, and subject matter experts to lead business process ...

Clinical Trial Coordinator needed in Cambridge, MA for a 1 year contract.  This is an immediate need, we are looking for someone to start in April!  Medical, Dental, 401K and life insurance will also be offered. The Clinical Trial Coordinator (CTC) supports the Clinical Trial Manager (CTM) in planning and co-ordination activities around the clinical trial all operational aspects of a clinical project. He or she has the responsibility to support the project team to achieve quality results in a cost ...

Our client is looking for a contracts manager in Weston, MA. This role will oversee the GMA-Hemophilia group responsible for setting up a Contracts Management database, liaise with Finance and Legal groups to ensure financial and reporting obligations are achieved for each agreement; monitoring and tracking all contract obligations, including event alerts to ensure event completion. Qualifications -Must have strong understanding of Contracts and Outsourcing, including understanding of legal, ...

Please read the entire job description below and if you are qualified, send your most current resume in a Word document to: [email removed] DUTIES: Manages all regulatory interactions with local health authorities in the US and Canada. Provides input into the development of regional RA strategies - Central contact point for all regulatory interactions with the respective local Health Authorities - Monitors local guidelines and vaccine specific recommendations - Prepares and/or comments on draft ...

Seeking 5+ years experience in medical device regulatory affairs registering medical devices in USA, Canada, Europe, and Latin America and track record serving as Regulatory Affairs Manager or Director position requiring the mentoring, coaching, and leading of a team and interfacing with the FDA, giving presentations for conferences and influencing KOL's. High growth visible position with top company. Salary $120,000 to $160,000 plus bonus plan; company paid full family coverage medical, dental, ...

Seeking 5+ years regulatory affairs experience with a diagnostics and-or medical device development and manufacturing company with a personal track record involving multiple successful submissions to the US, EU and Canadian regulatory agencies to: *** Provide strategic support to currently marketed products including; review of design and process changes, labeling, promotional materials and documentation for compliance and for changes requiring regulatory agency approval and notification. *** ...

Seeking Experience in the medical device manufacturing industry with a specific focus on regulatory compliance in the FDA Class I and II medical devices and track record successfully preparing documentation for 510(k) regulatory submissions and gaining approvals. Shall: *** Manage all Quality Assurance and Regulatory Affairs functions. *** Develop and implement global regulatory and compliance strategies. *** Instill a corporate culture of the development, maintenance and use of effective ...