Job ID: 7699
Job Title: Clinical Affairs Manager – Medical Device
Location: Marlborough, MA
Our client is a trailblazer in the medical device industry, dedicated to developing next-generation medical products powered by cutting-edge laser technology. Combining state-of-the-art engineering with a passion for innovation, the Company is at the forefront of creating advanced medical devices that set new industry standards. Their dynamic and collaborative environment fosters creativity and drives continuous improvement, ensuring their products remain at the pinnacle of medical technology.
Be a part of a company where innovation meets purpose—and help shape the future of medical technology.
Position: The Clinical Affairs Manager will report to the Director of Research and will be responsible for leading and coordinating clinical aspects of R&D projects. Ability to work independently is a must. Highly developed organizational and resource-planning skills are required. This position is also responsible for assisting other departments (marketing, engineering, regulatory, and QA) in investigating, verifying, optimizing, and validating prospective technologies from the viewpoint of clinical applications.
Responsibilities
- Conceives, plans, and executes clinical studies and tests of both existing and prospective medical products.
- Develop statistical and numerical approaches to optimize development of new products and technologies.
- Leads clinical project teams and ensures timely and within-budget execution of project phases.
- Work closely with clinical and pre-clinical partners in healthcare, academia, and industry.
- Evaluates prospective areas of research and avenues of product development and makes timely and relevant recommendations to the management.
- Writes scientific publications and presents papers at scientific/industrial conferences
- Develops, maintains, and leverages a thorough working knowledge of the Company’s current products
- Generates relevant IP and contributes to other publications (e.g., marketing)
- Interacts with other groups and departments of the Company, both providing necessary assistance and utilizing their resources to move projects forward.
- Provides supervision and guidance to junior scientists, engineers, students, and interns as required
- Participates in the integration and testing of system components and complete systems
- Prepares and maintains all necessary project documentation, ensuring compliance with relevant standards (Quality System, ISO 13485/FDA QSR, etc.).
- Assists the Medical Compliance Officer in ensuring impeccable compliance of all clinical work with the Medical Code of Compliance
Requirements
- MSc in Clinical Research or a similar field is required. A PhD in physics, biomedical engineering, or a similar field is preferred.
- At least 10 years of medical device R&D experience in an industrial/academic environment.
- At least 5 years of hands-on medical device clinical affairs management
- Class II electro-mechanical medical devices, electro-opto-mechanical systems, and optics-based medical devices experience a plus.
- Strong understanding of the fundamentals of laser medicine and biophotonics.
- Experience and skills in planning, organizing, and conducting clinical studies.
- Ability to quickly statistically process and reduce to meaningful conclusions large volumes of experimental data.
- Working knowledge of modern statistical analysis tools.
- Demonstrated ability to transform experimental results/conclusions into written reports and presentations.
- Understanding of design control process and Q.
- Ability to manage complex clinical study projects.
- Working knowledge of medical device standards, with emphasis on ISO, EU, and FDA documentation.
- Experience with mathematical software (MathCad, MatLab), database programming tools, and data processing tools.
