Cook Regentec (www.cookregentec.com), a Cook Group company, was founded in 2015 as an incubator and accelerator for emerging medical technologies. Our primary focus today is to innovate breakthrough medical devices for the preparation and delivery of advanced therapeutics, including cell, gene, and immunotherapies.
The Global Product Manager is responsible for the management of product globally in the regenerative medicine and cell therapy healthcare space, helping to implement emerging technology into the industry and expanding into new markets.
Work closely with internal and external stakeholders to implement the strategy for assigned product line(s) and ensure consistency in priorities, policies, compliance, processes, structure, and projects.
Execute product vision and strategy, develop and execute commercialization plans, lead establishment of technology pipeline and execute clinical strategy, including clinical trial activities.
Responsible to develop and execute an annual strategy and plan for assigned product line containing drivers, limiters, and enablers.
Manage product globally, including global registrations, market submissions, pre and post market data collection, distributor relationships, and contract submissions.
Develop and maintain sales/marketing tools and training/educational materials for customers, sales representatives, and distributors, and in support of clinical activities.
Responsible for the availability and efficiency of assigned product line.
Manage quarterly product forecasts and inventory levels.
Train and mentor inside and field representatives, ensuring they have the product and program knowledge to achieve CBD business objectives.
Demonstrate and maintain an extensive understanding of relevant market trends, including case volume, the regulatory environment, healthcare economics and the TPLC.
Develop and drive the product pipeline for assigned product line(s).
Collaborate with relevant internal and external stakeholders to identify and establish design input requirements.
Provide direction to engineering development and R&D efforts regarding product pipeline generation.
Assist in development and review of design controls, product design matrices, and risk analysis.
Lead and complete large and complex projects in a timely manner for planned and unplanned product specific events including, but not limited to, product launches, backorders and recalls, through collaboration with strategic marketing, sales, commercial business, regulatory, R&D, and manufacturing.
Help manage and establish relationships with clinicians, researchers, and industry partners, being the lead and liaison between business and technical segments of the organization.
Meet all deadlines for product related responsibilities such as business planning, product forecasts, etc.
Meet deadlines and complete administrative tasks such as expenses, training, reporting, policy acknowledgements, etc. in a timely manner.
Attend meetings with customers to understand needs, gain feedback and support the overall business.
Within scope of responsibility, ensure all quality, regulatory, compliance and product specific requirements are met.
Understand and be accountable for conducting Cook business with integrity and in compliance with applicable standards including Cook policies.
College degree in related field and/or equivalent relevant experience.
At least 5 years relevant work experience, including but not limited to, product management, engineering, sales and/or marketing.
Advanced degree (Masters or MBA or equivalent) may reduce the years of experience requirement.
Demonstrated experience leading projects or initiatives.
At least 5 years of experience in Product Management or equivalent in the medical device industry.
Demonstrates excellent communication, leadership, and presentations skills.
Demonstrates the ability to think strategically.
Physical Requirements/Work Environment:
Ability to travel internationally, domestically and weekends as needed up to 30%.
Work under general office environmental conditions.
Employee signs a non-competition and confidentiality agreements in relation to his/her
employment with Cook. Employee acts in compliance with company policies including but not
limited to, the Cook Employee Manual, Cook Code of Conduct, Cook Electronic Information
Policy, Product Complaints, HIPAA regulations and Cook Policy & Guidance on Interaction with