The Regulatory Project Manager position manages Medacta USA’s regulatory strategy. This includes coordination and completion of necessary product priorities, development and implementation of department processes and procedures, and support for the Medacta USA operations, R&D, marketing, and sales teams.
Bachelor’s Degree in Life Science or Engineering field or an associate’s degree in conjunction with 5+ years’ experience in the medical device field is required.
5 - 7 years’ experience in the Medical Device industry.
Strong interpersonal and communication skills.
Ability to communicate effectively both verbally and in writing.
Highly organized and detail oriented.
Ability to convey complex information in understandable terms to individuals throughout all levels of the company.
Ability to analyze and solve problems.
Ability to handle multiple tasks concurrently. Excellent time management skills.
Demonstrated knowledge of FDA medical device quality system regulations.
Experience with orthopedic and / or spine 510(k) submissions.
Medacta® is an international orthopaedics company specializing in the design and production of innovative orthopaedic products and the development of accompanying surgical techniques. Established in 1999 in Switzerland, Medacta’s products and surgical techniques are characterized by innovation. Medacta is a pioneer in developing new offerings on the basis of the minimally invasive surgical techniques, in particular its Anterior Minimally Invasive Surgery (AMIS®) technique for hip replacements. Medacta has leveraged its orthopaedic expertise and comprehensive understanding of the human body to develop the sophisticated MySolutions technology, which offers surgeons highly personalized pre-operative planning and implant placement methodologies by creating advanced personalized kinematic models and 3D planning tools for use in hip, knee, shoulder and spine procedures.