Clinical Affairs Manager - Medical Laser

Clinical Affairs Manager

IPG Medical Corporation is focused on developing next-generation medical products based on its state-of-the-art technology. Headquartered in Marlborough, MA, we aspire to work together with our employees and customers to apply light in ways that improve life.

Our mission is to develop innovative medical device laser solutions that make the world a better place. To accomplish this mission, we are committed to attracting and retaining the best talent and an engaged and thriving workforce that drives a sustainable future for our company and society.

The Clinical Affairs Manager will report to the Director of Research at IPG Medical 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, QA) in investigating, verifying, optimizing, and validating prospective technologies from the clinical applications viewpoint.

Duties

• Conceives, plans, and executes clinical studies and tests of IPG Medical products, both existing and prospective
• Develops statistical and numerical approaches to optimize development of new products and technologies
• Leads clinical project teams and ensures timely and within-the-budget execution of project phases
• Works closely with clinical and pre-clinical partners in health-care, academia and industry
• Evaluates prospective areas of research and avenues of product development, makes timely and relevant recommendations to the management of IPG Medical
• Writes scientific publications and presents papers at scientific / industrial conferences
• Develops, maintains, and leverages 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 (IPG MD Quality System, ISO 13485 / FDA QSR etc)
• Ensures a safe, healthy and environmentally-friendly workplace by observing Company's procedures and ISO 14001 regulations. Actively engages in prevention, elimination of potential safety hazards and participation in activities which promotes recycling, replacement and reduction of resource materials
• Assists IPG Medical Compliance Officer in ensuring impeccable compliance of all clinical work with IPG Medical Code of Compliance