Manager, Regulatory Affairs Salary at Corza Medical BETA

Residency Requirement: Employees must be Boston residents on their date of hire and for the duration of their employment subject to BWSC policies and collective bargaining agreements. Overview: Position Purpose: Performs professional and technical work related to the engineering activities of the Commission. Responsible to assist and coordinate water, sewer and storm drainage related to planning, engineering and environmental projects and programs. Responsibilities: Essential Functions: (The essential functions or duties listed below are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related or a logical assignment to the position.) Review, manage and prepare Environmental Notification forms, Environmental Impact Reports and notices of project changes as required by the Executive Office of Environmental Affairs and Boston Planning and Develop

Job Title: Lead Quality and Regulatory Manager Location: 18 Tower Office Park, Woburn, MA Department: Quality management Reports To: COO Type: Full-Time ________________________________________ Company Description Stemwave is a Medical Device startup with locations in the Seaport and Woburn, MA. We are among the fastest growing orthopedic shockwave devices in the United States and are rapidly innovating our product in effort to reach best-in-class status. Ranked as the 227th fastest growing privately-owned startup in 2023, we are looking to continue expanding our team and increasing our capabilities. We are a young company looking for passionate and driven individuals that are eager to make a difference and looking for growth opportunities. Stemwave is an equal opportunity employer and we welcome applicants from diverse backgrounds. Learn more: www.stemwave.com ________________________________________ Position Summary The QMS Manager will lead the maintenance, improvement, and complian

Job Title: Director of Human Resources Location: Lowell, MA Reports To: Chief People Officer (CPO) Job Purpose: The Director of Human Resources (HR) oversees all aspects of human capital management within the organization, ensuring alignment with business objectives. They lead the HR department in developing and executing HR strategies that support organizational goals, foster employee development, and enhance employee engagement. Key Responsibilities: 1. Strategic HR Leadership: Develop and implement HR strategies and initiatives aligned with the overall business strategy. Bridge management and employee relations by addressing demands, grievances, or other issues. Nurture a positive working environment and promote the organization’s core values. 2. Employee Development and Performance Management: Develop and implement performance management systems to enhance employee productivity. 3. Compensation and Benefits Administration: Develop and monitor overall compensation and benefits packa

Company Description Would you like to contribute to exciting digital transformation projects with people who are passionate about innovation? With TeamWork Management, the possibilities are endless. We are a local fast-growing company with a global reach, powered by the Swiss group TeamWork Corporate and 20 years of uninterrupted growth. Joining our TeamWork Management subsidiary in Boston means being part of our US-based team with 60 information technology specialists in a fun environment where diversity and international talent are put forward. We offer opportunities for continuous learning, a robust benefits package, remote work flexibility, and lots of company perks! Who are we? TeamWork is an independent international group, founded in 1999 in Geneva by our current CEO Philippe Rey-Gorrez. We are your strategic partner in digital transformation, specializing in four core businesses: Management Consulting, SAP Business Solutions, Data Analytics and Technology Platforms. Recognized

Position Overview We are seeking a seasoned regulatory affairs professional to lead the post-market compliance operations within our regulatory team. This role focuses on overseeing critical post-market functions including incident reporting, global compliance submissions, and product surveillance. The successful candidate will be responsible for managing a team, engaging with international regulatory bodies, and driving continuous improvement in regulatory processes. Key Responsibilities Post-Market Compliance & Surveillance Lead all post-market surveillance activities, ensuring compliance with regional and international regulatory standards. Review and approve documentation related to adverse event reporting, device malfunctions, and corrective actions. Oversee development and execution of post-market surveillance strategies and risk assessments. Coordinate and conduct health hazard evaluations in collaboration with cross-functional subject matter experts. Ensure proper execution and

Manager, Clinical Operations SanegeneBio Woburn, MA Company Overview: SanegeneBio is a clinical-stage biotechnology company developing innovative RNAi-based genetic medicines. Our proprietary LEAD™ (Ligand and Enhancer Assisted Delivery) RNAi platform drives a growing pipeline across cardiometabolic and complement-mediated diseases. With R&D operations in Boston, Suzhou, and Shanghai, we are committed to scientific excellence, integrity, and collaboration. Position Overview: We are seeking a highly organized and experienced Clinical Operations Manager to join our dynamic clinical research team. The ideal candidate will possess a robust background in managing clinical trials, particularly in the areas of nephropathies, including IgA Nephropathy (IgAN), C3 Glomerulopathy (C3G), and other related kidney diseases. This role will involve overseeing the planning, execution, and management of clinical trials, ensuring compliance with regulatory requirements, and maintaining high standards of

If your location allows for pay/benefit transparency, please click the link below to request further information on this position. Pay Transparency Request Form PURPOSE AND SCOPE: Assists in the support of the daily operational activities within Regulatory Affairs for the preparation of regulatory submissions required to market new or existing licensed pharmaceuticals and device products in the domestic and international markets as assigned. Maintains systems designed to ensure compliance with electronic submission requirements and document management systems. PRINCIPAL DUTIES AND RESPONSIBILITIES: A seasoned, experienced professional with a full understanding of Regulatory Affairs; resolves a wide range of issues in creative ways. Responsible for the preparation, compilation, quality check and delivery of regulatory submissions in both paper and/or electronic format in accordance with regional requirements and company standards. Works closely with contributing functional departments t

Job Title: Research and Development Regulatory Affairs Manager Reports To: Vice President - Research and Development SUMMARY The Manager, Regulatory Affairs is responsible for regulatory compliance and label accuracy for all products. This person should be experienced in interpreting regulations and implementing sound guidance and company policy to comply with applicable regulations in the United States. ESSENTIAL DUTIES AND RESPONSIBILITIES: • Assures ingredients, formulas, labels, and packaging are in full compliance with laws and regulations in countries where they are sold. • Collaborates with the graphic design and packaging project management team to execute labeling initiatives. • Identifies and provides resolution to strategic and tactical regulatory issues pertaining to food labeling. • Review and approve any changes to existing raw materials. • Conducts impact assessment of key guidance documents and regulations. • Maintain regulatory files/databases and chronologies in good