Professional - Project Manager – Quality & Regulatory Affairs - Marlborough

The Regulatory Affairs Leader - Pharma may be involved in Pre or Postmarket duties or both. · File / Maintain regulatory deliverables. · Analyze & communicate changes and proposed changes to country regulations through Regulatory Intelligence and implement strategies. · ...

We are seeking a Manager to join our team in Regulatory Affairs. The successful candidate will be responsible for managing regulatory submissions, providing technical guidance to the team, and developing short-range regulatory strategies. · Direct and coordinate activities of Reg ...

Job summary · Boston Scientific is seeking a Regulatory Affairs Manager to support the Urology business unit. The successful candidate will be responsible for supporting existing product lines, developing new technologies, and managing CAPAs. · ResponsibilitiesDirect and coordina ...

This role involves providing regulatory expertise on multiple products, technologies, and regions. · As a Regulatory Subject Matter Expert (SME), you will devote significant time to leadership at both the franchise level and functional level, · including department employee devel ...

Boston Scientific busca un especialista en asuntos regulatorios senior para apoyar su estrategia global de productos endoscópicos. · ...

Sumitomo Pharma Co., Ltd. is seeking a dynamic leader for the position of Vice President, Regulatory Affairs Oncology. The candidate must have recent Oncology NDA submission experience and submissions worldwide including HTA submissions. · Demonstrate communication and collaborat ...

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Director Regulatory Affairs. · , · _leads_and_coordinates_project_team_members_in_developing_strategy_for_applicable_documents/_activities_. · , · _plans,_coordinates,_authors,_ ...

We are seeking an experienced Project Manager to lead and support large to mid-sized initiatives within the Quality & Regulatory Affairs function. · This role requires strong leadership, stakeholder management, and program oversight skills to successfully drive projects from init ...

Akkodis is seeking a Regulatory Affairs Project Manager for a contract. Required PMP certification, 7–10 years project management experience and strong data analysis and problem solving. · Equal Opportunity Employer/Veterans/Disabled. · ...

Boston Scientific offers a role for Senior Regulatory Affairs Specialists in their Endoscopy division. The ideal candidate will have experience across U.S., EU, China, and other international markets to support expansion efforts and ensure global compliance. · This role will play ...

This is a Regulatory Affairs Chemistry Manufacturing and Controls (CMC) role at Artech in Westborough, MA. · ...

The Regulatory Support Manager will provide support to Product Managers Regions and Customers by providing quality documents and regulatory support in response to customers requests for quality regulatory and technical-related information. · ...

As a Regulatory Affairs Specialist at Mass General Brigham, you will be responsible for ensuring compliance with regulatory requirements and maintaining an updated library of FDA regulations and guidance documents. · AUTHORS AND REVIEWS OF STANDARD OPERATING PROCEDURES,T techNICA ...

This position will lead or support a variety of large to medium size projects within Quality and Regulatory Affairs function. · Bachelors Degree - REQUIRED · Formal training in project management or continuous improvement methodologies (e.g., Six Sigma, Total Quality Management, ...

This position will lead or support a variety of large to medium size projects within Quality and Regulatory Affairs function. · Leads projects and working teams to effectively initiate, plan, execute, monitor, and close projects. · Owns the timeline budget resource constraints de ...

This is a full-time, permanent opportunity for a Senior/ Principal Regulatory Affairs Specialist in Marlborough. The role integrates with engineering and clinical teams to support two IDE programs and accelerates global submissions. · ...

This Senior/ Principal Regulatory Affairs Specialist will integrate with engineering and clinical teams to contribute to bench work design discussions early drafting of submissions This full-time permanent opportunity offers a competitive salary comprehensive benefits package qua ...

The Regulatory Affairs Manager reports to the Director of Regulatory Affairs and is responsible for executing regulatory strategies, ensuring compliance with global regulations and leading the process to obtain and maintain market approval for DeepHealth's product and product dev ...

Job summary · Regulatory Affairs Manager for medical devices company. · Partner closely with the Director of Regulatory Affairs to define and implement regulatory strategies. · Provide regulatory guidance during product development to ensure compliance. · ...

We are looking for a talented and detail-oriented Regulatory Affairs Specialist with 2-3 years of experience in regulatory affairs, · specifically with expertise in regulatory codes, particularly USDA codes.Ensure compliance with regulatory standards and codes governing the food ...

The Regulatory Affairs Manager is responsible for executing regulatory strategies and ensuring compliance with global regulations. They will lead the process to obtain and maintain market approval for DeepHealth's product and product development. · Oversee the day-to-day function ...