Clinical Affairs Manager – Medical Laser – Marlborough, MA

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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

experience Required:

• At least 10 years of medical device R&D experience in industrial/academic environment
• At least 5 years of hands-on medical device clinical affairs management

Essential Skills Required:

• Strong understanding of fundamentals of laser medicine and biophotonics
• fluency in the state-of-the-art knowledge in the field
• 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 studies projects
• Working knowledge of medical device standards, with emphasis on ISO, EU, and FDA documentation
• Experience with mathematical software (MathCad, MatLab), database programming tools, data processing tools
• Travel may be required 1-5 % of the time

education Required:

• MSc in Clinical Research or similar field required
• PhD in physics, biomedical engineering or similar field preferred

Personal Requirements:

• Excellent oral and written communication (English), and interpersonal skills
• Ability to work independently
• Must be able to interact with customers, KOLs, consultants, and academic/industrial partners
• Ability to work in an environment with competing priorities is necessary
• Must be able to work in a cross-functional team environment

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