Regulatory Specialist Salary at Mfs Ltd BETA

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia, and the Americas. Job Overview. We are seeking a Senior QA/RA Specialist to help shape the future of oral care through the intersection of quality, regulatory processes, and innovative technologies. In this pivotal role, you will work closely with the Machine Learning (ML) and Operations teams, contributing your expertise to the development and growth of a robust Quality Management System (QMS) for software as a medical device (SaMD). As a key member of the Quality & Regulatory Department, you will play a critical role in driving the implementation of QA/RA and security software modules while collaborating on cybersecurity management alongside the Information Security Officer. Responsibilities: Lead the development and implementat

The Regulatory Affairs Specialist (RAS) positions provides advanced expertise and regulatory support to 600+ investigators and research staff members at DFCI, focusing on standards and techniques for performing job functions typical in the development and/or conduct of FDA regulated research from an operational and regulatory compliance perspective. These positions currently support 25 research groups within DFCI and works with the investigators and study teams at various time points during a research protocol lifecycle. This includes but is not limited to external audit coordination and responses, assistance in determining which regulations apply to their research, consultation and education regarding regulatory requirements, review of FDA submissions for investigator-held IND or IDE research, and review of select protocol and monitoring processes prior to IRB review. The Regulatory Affairs Specialist (RAS) positions are critical to successfully achieving ongoing clinical research exp

Job Title: Clinical Quality Compliance Lead Location: Cambridge, MA Position Overview: We are seeking an experienced Clinical Quality Compliance Lead to provide strategic quality oversight for clinical trial delivery systems. This role is critical in ensuring compliance with GCP regulations and promoting a culture of continuous improvement, operational excellence, and proactive quality risk management. The ideal candidate will be a thought partner to the Head of GCP Quality Compliance and play a key role in developing and executing global GCP compliance strategies. Key Responsibilities: Lead the development and execution of the clinical trial inspection readiness program. Partner with cross-functional teams (e.g., Global Development Office, Regulatory Affairs, Legal) to ensure ongoing readiness and regulatory compliance. Monitor emerging regulations and provide strategic guidance on inspection preparedness. Serve as the lead host during GCP inspections, managing daily communications, r

Director, Regulatory Affairs - CMC (Individual Contributor) Location: Flexible (U.S. based only, remote or hybrid options available) Employment Type: Full-time Summary: A growing biopharmaceutical company is seeking a Director, Regulatory Affairs - CMC to lead global regulatory CMC activities for late-stage and commercial products. This individual will act as a subject matter expert and strategic advisor across manufacturing changes, lifecycle management, and global agency engagement. Key Responsibilities: Develop and execute global CMC regulatory strategies for assigned products across clinical development, marketing applications, and post-approval lifecycle management. Act as the regulatory lead on cross-functional CMC and submission teams. Drive the preparation, authoring, and review of CMC components of global regulatory submissions (e.g., INDs, IMPDs, NDAs, MAAs, amendments, annual reports). Lead regulatory interactions with global health authorities (FDA, EMA, PMDA, etc.), includ

Responsibilities: The role requires strong US, EU, China, and international regulatory experience that can be leveraged to help support international expansion. This is a hybrid role (in office 3 days per week) based in Marlborough, MA. Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams. Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review. Assists with developing and implementing regulatory strategies for new and modified medical devices, as well as for OEM and Contract Manufacturer partnerships. Is a liaison for new business partners to provide regulatory guidance for US, EU, China, and international product registration. Acts as a core member on manufacturing and development te

Responsibilities: Developed and optimized efficient, cost-effective, and validated manufacturing processes for medical devices, focusing on capital and/or disposable devices, including assembly, lot release testing, sterilization, and packaging. Produce production-level assembly and part drawings for all components and sub-assemblies. Incorporate Design for Manufacturing (DFM), Six Sigma, and LEAN principles into product and process designs to ensure manufacturability, minimize costs, and achieve optimal production efficiency through activities like DFMA reviews and cycle time optimization. Proactively identify and evaluate potential contract manufacturing partners by analysing quality, cost, delivery timelines, and regulatory compliance capabilities to recommend optimal providers. Lead and collaborate with contract manufacturers in selecting and developing the most efficient and reliable manufacturing processes and sites while fostering strong partnerships. ct as the liaison between C

Job Description Job Description Job Description We have multiple openings for Life Science Quality Assurance Analysts, Regulatory Affairs Specialist, and Quality Control Analysts. All of these roles will interface with clients on different projects to provide consulting services. We are seeking entry-level experienced personnel or fresh graduate students willing to be trained as per our client's requirement and able to relocate. Most of our openings require 3-4 days' onsite presence at the client site. Minimum Qualification: 0-3 years of experience in life science (pharmaceutical, biology, chemistry, bioinformatics) or engineering industry with a focus on information technology, clinical research, quality, regulatory affairs, manufacturing, or supply chain. Minimum bachelor’s degree in the above concentration. Valid US work authorization. Virtually able to participate in our training program. Able to relocate anywhere in the US. About White Collar Technologies Inc. is one of the fastes

About Us: Prom USA, Inc. is a global provider of innovative biocide solutions, dedicated to improving public health and safety across diverse industries. We are committed to delivering quality products while ensuring compliance with global regulatory standards. As we continue to grow and expand, we are looking for a dynamic and experienced Global Regulatory Affairs Director to lead our regulatory strategy across markets worldwide. Job Overview: As the Global Regulatory Affairs Director, you will be responsible for overseeing the development, implementation, and management of regulatory strategies to ensure our biocide products are in full compliance with applicable global regulatory frameworks. You will collaborate with internal and external stakeholders to navigate the complex landscape of biocide regulations, driving product approvals and market access globally. Your leadership will be key to shaping the company's regulatory affairs strategy and advancing the global reach of our prod