Healthcare Pharmaceutical jobs in Massachusetts

Take charge of crafting and submitting crucial regulatory paperwork, such as Investigational New Drug Applications (INDs), Biologics License Applications (BLAs), Investigational Medicinal Product Dossiers (IMPDs), and Clinical Trial Applications (CTAs). Spearhead and oversee the dynamic realm of Regulatory Affairs CMC endeavors, with a distinct focus on biologics and the evolution of drug development.

The Quality Manager is responsible for overseeing and managing all aspects of the quality assurance and control process for Class III OEM products. This includes establishing and maintaining quality management systems, ensuring compliance with industry and regulatory standards, and driving continuous improvement initiatives.

As a Lead Manufacturing Engineer, you will play a vital role in the development and manufacturing processes of Class 2 and 3 medical devices. Your primary focus will be on clean room operations and disposable medical device manufacturing.

The Advanced Manufacturing Engineer will be a key member to design and validate medical devices including product improvement and technology transfer.

This is the perfect role for an experienced and highly motivated Principal Mechanical Engineer to drive the design, development, and implementation of electromechanical medical devices in accordance with regulatory standards and industry best practices. The successful candidate will lead cross-functional teams, mentor junior engineers, and collaborate with various stakeholders to ensure the successful delivery of safe and effective medical devices..

The Head of R&D will be responsible in leading the entire organizations engineering efforts to advance development on a potential industry leading mapping system.

The Systems Engineer will work across all teams on the development of our mapping system. Understanding signal processing, electrical system design, and medical device development are key to success in this position.

As the leader of IND enabling studies through clinical proof of concept clinical trials, this role ensures seamless coordination with the project lead to maintain the program's success within established timelines and budgetary constraints. Upholding a commitment to excellence, the individual guarantees high-quality execution and adherence to domestic and international regulations, ensuring the utmost integrity in all aspects of the research process.

As the Director of Marketing and Product Management, you will play a pivotal role in shaping the success of our medical device products. You will be responsible for developing and executing strategic marketing plans, driving product development, and ensuring our products meet the needs of health care professionals and patients alike. This role combines strategic thinking, leadership, and a deep understanding of the medical device industry.

We are seeking a highly motivated and experienced Clinical Product Manager to join our client in Norwood, Massachusetts. The Clinical Product Manager will play a crucial role in the development and management of our instrumentation products in the clinical space. This position requires a deep understanding of the biotechnology industry, clinical trials, and regulatory requirements, as well as strong project management and communication skills.

The Principal Electrical Engineer will be designing medical devices and components in the plasma and blood heathcare industry. The Principal Electrical Engineer will lead projects through design and into production to grow a vast portfolio of products.

Assist and oversee clinical research projects by executing study plans and managing site setup procedures, including qualification, initiation, recruitment, and follow-up, to aid in bringing products to market. The chosen candidate will collaborate with clinical site personnel, field monitors, clinical case support, Clinical Research Organizations (CROs), suppliers, and help Quality and Regulatory Affairs in adhering to Good Clinical Practices.

Spearhead the creation, execution, and oversight of the Clinical Quality Assurance initiative. Offer seasoned expertise in Good Clinical Practice (GCP), Good Laboratory Practice (GLP), International Conference on Harmonisation (ICH), and FDA regulations to ensure exceptional regulatory adherence and excellence in clinical operations.

A key contributor in the development of a late stage catheter product. The small start up continues to make strides towards their product hitting the market in the next few months.

As a Engineering Manager, you will lead the design, development, and commercialization of our novel combination devices. In this role, you will be responsible for managing and executing all aspects of device development, from concept generation and prototyping to validation and manufacturing transfer.

The emerging medical device combination product is seeking a talented Product Development Manager to lead a team of engineers through the clinical stages of a product trying to go to market

This is the perfect role for an experienced and highly motivated Principal Mechanical Engineer to drive the design, development, and implementation of electromechanical medical devices in accordance with regulatory standards and industry best practices. The successful candidate will lead cross-functional teams, mentor junior engineers, and collaborate with various stakeholders to ensure the successful delivery of safe and effective medical devices..

Prepare and submit regulatory documents, including Investigational New Drug Applications (INDs), Biologics License Applications (BLAs), Investigational Medicinal Product Dossiers (IMPDs), and Clinical Trial Applications (CTAs). Lead and manage Regulatory Affairs CMC activities, specializing in biologics and drug development.

Lead the development, implementation, and management of the Clinical Quality Assurance program. Provide expert guidance on Good Clinical Practice (GCP), Good Laboratory Practice (GLP), International Conference on Harmonisation (ICH), and FDA regulations.

Looking for an experience construction executive looking to help lead, manage and grow one of Boston's most established contractors!

Join our client which has 28+ products in their portfolio and are commercialized in 90+ countries.

Reporting to the Director of Quality, the Quality Manager, will perform tasks that will uphold and improve the product quality of the medical devices manufactured and meet regulatory requirements to stay in compliance for the Burlington Manufacturing site.

Elevate the company's prominence by fostering beneficial collaborations, advocating our integrated services to potential partners. This role bridges science and business, building enduring relationships while aligning drug discovery and CMC capabilities

This role offers a pivotal opportunity, reporting to senior leadership, to strategically oversee relationships with major pharmaceutical companies for Discovery/R&D services. My client is seeking an accomplished Director with a background in Big Pharma, skilled in managing External Discovery Collaborations, now bringing their expertise to foster commercial CRO partnerships at the highest level.

The Principal Mechanical Engineer will be responsible for the hands on design and implementation of new process development ideas to grow the portfolio of products over the next several years. They will continue to test and sustaining current product lines to efficiently continue to be an industry leading in the market.

My client is seeking a Lead Quality Training Specialist to head up their training programs at their site in Billerica. Reporting to the VP of Quality Compliance, this role will be responsible for the overall training of the quality staff internally including creating and driving lesson plans in a classroom environment in line with the regulations and standards from my client.

Pre-IPO biotech business seeks CFO to steer them successfully through a public listing.

This is the perfect role for an experienced and highly motivated Principal Mechanical Engineer to drive the design, development, and implementation of electromechanical medical devices in accordance with regulatory standards and industry best practices. The successful candidate will lead cross-functional teams, mentor junior engineers, and collaborate with various stakeholders to ensure the successful delivery of safe and effective medical devices..

As a Research Scientist in Bioanalytical Assay Development at my client's company, you will play a crucial role in designing, optimizing, and validating bioanalytical assays to support drug development. Your expertise will contribute to the advancement of novel therapies, ensuring accurate and reliable data for crucial decision-making processes, and ultimately, improving patients' lives through innovative treatments.

Responsible for overseeing IND enabling studies through clinical proof of concept clinical trials. Working with the project lead, S/he ensures the program remains on-time and on-budget with high-quality execution and conduct in compliance with domestic and international regulations.

We are seeking a talented and experienced Director of Scientific Marketing to lead our marketing efforts within the global life sciences community. As the Director of Scientific Marketing, you will be responsible for developing and executing effective marketing strategies, strengthening the market position, and driving customer engagement.