Overview

Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.

The Product Manager II at Cook MyoSite, Inc. is responsible for the progress and management of assigned medical devices, products, and/or service lines as applicable.

Responsibilities

• Execute the strategy for the devices/products/service lines lifecycle, with input from Manager and Executive Leadership. • Lead medical devices/products/service lines lifecycle projects by collaborating with various departments, vendors, and collaborating companies. • Serve as an expert on MyoSite products and services and therefore is a resource for others. • Support innovation and product/service development by staying current with industry and market trends and disseminating information to internal stakeholders. • Develop and maintain relationships with product- and/or service-line stakeholders to ensure the development and commercialization of products/services which fulfill the needs of and improve the customer experience. • Seek opportunities for product/service lifecycle and departmental improvement and efficiencies. • Follow applicable Standard Operating Procedures and Business Operating Procedures, and develop new Business Operating Procedures, as necessary. • Serve as the voice of the customer to organizational stakeholders and facilitates product/service-related communication between internal and external stakeholders.• Identify, establish, support, and develop relationships with key internal and external stakeholders. • Be responsible for maintaining existing and developing new supporting medical devices and accessories, as applicable.• Work with Regulatory Affairs and Quality Units to ensure compliance on all assigned devices/products/service lines.• Be the technical expert on the assigned devices, products, and/or services, as well as the customer environments in which they are/will be used.• Support product development by communicating customer experiences and providing feedback to Product Development, Clinical Development, Marketing, Operations, Engineering, Regulatory, and other internal groups.• Support new product launches.• Provide content and informed opinions to help build strategy and infrastructure for commercial readiness for new products and services• Support commercial products and services through ongoing maintenance and product-improvement opportunities, as applicable.• Attend conferences and meetings to stay informed on industry trends.

Qualifications

• Undergraduate degree in Business, Life Sciences, or Engineering or any related field or 3 years’ direct, relevant experience in pharmaceutical/biotech/medical device Product Management to provide a comparable background

• Graduate degree in Business, Life Sciences, or Engineering field is preferred

• Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing• Proficiency or comfort level working with material of a highly technical or scientific nature

• Advanced proficiency in MS Office, specifically, advanced knowledge of Project, Adobe, OneNote, Excel, Word and PowerPoint; Expert in Outlook

• Must maintain company quality and safety standards

• Ability to work in collaborative and independent work situations and environments with minimal supervision

• Maintain composure and competence under stressful situations; demonstrate flexibility and adaptability 

• Must maintain a high level of professionalism, business acumen, and excellent customer service skills

Physical Requirements:

• Remote/Field-based position | General office or home office setting

• Travel (Domestic & International): 30-40%

• Ability to conduct and hear ordinary conversation and telephone communication.• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.• Ability to work under specific time constraints.• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.• Visual and manual acuity for working with computers and equipment.