11/21 | Cubist Pharmaceuticals (NASDAQ: CBST) is a biopharmaceutical company focused on the research, development and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. Founded in 1992, Cubist is headquartered in Lexington, MA. Description Please note that Cubist will be participating in the Regulatory Affairs Professionals Society (RAPS) Virtual C | Cubist Pharmaceu... | Lexington | | map | | | action |
11/20 | Hologic, Inc. (NASDAQ: HOLX) is a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems, and surgical products dedicated to serving the healthcare needs of women throughout the world. Historically, Hologic developed, manufactured, and marketed products focused on mammography, breast care, and osteoporosis assessment. In 2007, we expanded our focus and now pro | Hologic, Inc. | Bedford, MA, 017... | | map | | | action |
11/20 | An Aerotek client, a leading medical device manufacturer, is seeking a Regulatory Affairs Associate. The RAA will be preparing submissions to obtain and maintain global regulatory approvals for clinical research and commercial distribution of Endoscopy products. Will provide technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams. Will a | Aerotek | Boston, MA, 0210... | | map | | | action |
11/20 | Associate/Senior Associate, Regulatory Operations Job Code: JFRA Functional area: Clinical, Biometric and Regulatory Affairs To apply, send email with a subject of “Job Code JFRA” to careers@ironwoodpharma.com. Please include a CV and cover letter with your email message. Position description: Reporting to the Associate Director, Regulatory Operations, the Senior Associate of Regulatory Operations | Ironwood Pharmac... | Cambridge, MA, 0... | | map | | | action |
11/19 | Advanced Clinical is seeking a Manager of Regulatory Affairs to join an organization dedicated to delivering innovative products that improve the lives of patients every day. This position is located in the Boston area. In this position, the Manager, Regulatory Affairs, will direct and coordinate the activities of Regulatory Affairs employees, including direct supervision of related team. Provide d | Advanced Clinica... | Boston, MA | | map | | | action |
11/18 | AMICAS is searching for a motivated and experienced Sr. Quality Systems Analyst to join our Team! POSITION PURPOSE: The Senior Regulatory Affairs Specialist is a member of the Quality & Regulatory Affairs Team responsible for assisting the Executive Director of Regulatory Affairs and Quality Systems in support of generating and managing quality system data. This position reports on the effectivene | AMICAS | Boston, MA, 0213... | | map | | | action |
11/18 | CDM is looking to hire a Regulatory Compliance Auditor to lead environmental, health and safety compliance audits at facilities throughout the United States. Job responsibilities include: • Lead environmental, health and safety (EHS) compliance audits at client facilities and evaluate compliance with federal, state and local environmental laws, regulations and permits. • Evaluate compliance by rev | CDM | Multiple locatio... | | | | | action |
11/18 | Billerica, MA Corporate Headquarters Position Summary: This position reports to the Corporate Director of Regulatory Affairs. The responsibilities of the position include implementing regulatory plans, interpreting and communicating regulatory policies and procedures to the various manufacturing operations, and successfully interfacing with other corporate functions in order to ensure representati | Millipore | Billerica, MA, 0... | | map | | | action |
11/17 | Myriant is a privately-held science and technology company leading the development and commercialization of next generation biorefineries for the production of high-value bio-based chemicals from renewable feedstock, through the use of its proprietary biocatalyst technology. Summary: Myriant’s Regulatory Manager will work with the business on the planning, development and implementation of environ | Myriant Technolo... | Quincy, MA, 0216... | | map | | | action |
11/17 | Description Job Summary As we approach the commercialization phase of our first product, DX-88, a novel therapeutic for the treatment of Hereditary Angioedema, Dyax is adding new skill sets to our Development teams to meet this exciting new stage of evolution in the organization. The Senior Regulatory Affairs Specialist will participate to regulatory submission strategy, planning and implementatio | Dyax Corp. | Cambridge | | map | | | action |
11/16 | MRINetwork™ is the world’s largest executive search and recruitment organization. We have a global network of more than 1,000 offices. Management Recruiters - The Boston Group is our 5 office organization, established in 1966 to provide executive and management level staffing services to a wide variety of industries. COMPANY INFORMATION The Client’s mission is to bring the medical marvel of regene | MRINetwork | Canton, MA, 0202... | | map | | salary | action |
11/13 | Sr. Regulatory Affairs Manager Medical Devices A medical device manufacturing company located in the Boston area has an urgent need for a Regulatory Affairs professional with experience in 510k preparation and submissions, complaint handling, labeling, adverse event reports, and general regulatory affairs issues in the medical device industry. This is a strong and growing company with excellent pr | MRINetwork | Boston, MA | | map | | salary | action |
11/13 | Primary Role: The Associate Director of Regulatory Affairs will formulate and implement regulatory strategy, provide guidance to program teams and sub-teams, resolve complex issues related to assigned projects, and assure compliance with timelines and milestones to meet business needs. Primary roles include: • Utilizing regulatory expertise and knowledge of regulatory requirements and regulations t | Shire Pharmaceut... | Lexington, MA, 0... | | map | | | action |
11/12 | As a medical device startup company, the duties and responsibilities of this position will evolve every day, but the position will have responsibility for leading and supporting our regulatory efforts. Responsibilities may include but are not limited to: · Develop regulatory strategies, systems and processes to ensure that the Company’s development, approval application, registration and commercia | InVivo Therapeut... | Cambridge, MA, 0... | | map | | salary | action |
11/12 | Under supervision responsible for monitoring and maintaining inventory to ensure appropriate and adequate supplies for assigned facilities within the centralized program. Assists in ensuring that OSHA and other regulatory requirements are met. Responsible for cost containment with regard to inventory control and maintenance of supplies. Supports the FMCNA mission, vision, values, and customer serv | Fresenius Medica... | Webster, MA, 015... | | map | | | action |
11/11 | Cubist Pharmaceuticals (NASDAQ: CBST) is a biopharmaceutical company focused on the research, development and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. Founded in 1992, Cubist is headquartered in Lexington, MA. Description Please note that Cubist will be participating in the Regulatory Affairs Professionals Society (RAPS) Virtual C | Cubist Pharmaceu... | Lexington | | map | | | action |
11/11 | Summary: Support international regulatory affairs activities, including but limited to: support of new product development teams, preparation and submission of regulatory documentation for product registration/licensing in selected markets. Assist Manager, International Regulatory Affairs in obtaining approval to market Gyrus ACMI medical devices, in the worldwide markets served by Gyrus ACMI: · P | Gyrus/Olympus | Southborough, MA | | map | | | action |
11/10 | Job Title VP, Regulatory Affairs Syntonix Location Cambridge,MA Requisition Number 11262BR Job Description The Head of Regulatory Affairs for Syntonix will provide leadership, strategic direction and day-to-day oversight of global regulatory development and registration activities. He or she will play a pivotal role in devising and implementing innovative regulatory approaches that allow us to rap | Biogen Idec | Boston, MA, 0214... | | map | | | action |
11/10 | Hologic, Inc. (NASDAQ: HOLX) is a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems, and surgical products dedicated to serving the healthcare needs of women throughout the world. Historically, Hologic developed, manufactured, and marketed products focused on mammography, breast care, and osteoporosis assessment. In 2007, we expanded our focus and now pro | Hologic, Inc. | Bedford, MA, 017... | | map | | | action |
11/09 | Regulatory Affairs Operations Manager The Regulatory Affairs Operations Manager is responsible for managing the planning process and timelines for major submissions, ensuring that the deliverables meet applicable regulatory requirements and that the product team completes the project. Responsibilities: Develop and maintain the Project Plan with the team and Manage the team performance of project t | MRINetwork | Boston, MA | | map | | | action |
11/05 | Summary: The Regulatory Submission Specialist executes and maintains document management processes and electronic common technical document publishing processes in a validated internal system enterprise, and serves as first-line document management system support for internal and external stakeholders. Position Overview: The Regulatory Submission Specialist performs desktop publishing for regulato | ARIAD Pharmaceut... | Cambridge, MA, 0... | | map | | | action |
11/05 | Summary Coordinates and prepares submissions to regulatory authorities worldwide. Compiles all materials required for submissions. Reviews and approves clinical trial submissions prepared by external sources. Keeps abreast of regulatory procedures and practices. Develops and documents department best practices. Duties and Responsibilities · Liaise proactively with other functions and participate a | ARIAD Pharmaceut... | Cambridge, MA, 0... | | map | | | action |
11/05 | Regulatory Affairs Manager Medical Devices A medical device manufacturing company located in the Boston area has an urgent need for a Regulatory Affairs professional with experience in 510k preparation and submissions, complaint handling, labeling, adverse event reports, and general regulatory affairs issues in the medical device industry. This is a strong and growing company with excellent promot | MRINetwork | Boston, MA | | map | | salary | action |
11/04 | Job Description: Summary: Responsible for multiple product lines, technologies and specialized functions. Devotes a significant portion of time to managerial, leadership and employee development responsibilities. Responsibilities: Directs and coordinates activities of Regulatory Affairs employees, including direct supervision of related team. Provides day to day management of Regulatory Affairs fu | Boston Scientifi... | Marlborough, MA,... | | map | | | action |
11/04 | Senior Associate/ Associate, Regulatory Operations Our client is an entrepreneurial pharmaceutical company focused on the development of medicines to target important human needs. They are experiencing significant growth and recently received positive results from a phase III trial for their lead compound. This is a great opportunity to join a company that offers potential for you to leverage your | MRINetwork | Cambridge, MA | | map | | | action |