Hyalex Orthopaedics is an award winning, venture funded medical device start-up developing transformational synthetic cartilage technology and implant systems for diseased and damaged joints. We address unmet clinical needs to improve patient quality of life so that we all can Be Active and Stay Active. Our Hyalex team is comprised of industry leaders, innovators, and experts who have developed and launched many successful commercial products as well as a team of brilliant engineers, scientists and medical professionals.
The Vice President of Clinical and Regulatory Affairs leads the development and execution of the clinical and regulatory strategies for the Company. This individual provides leadership, strategic direction, and coordination of all activities established to support/gain rapid market introduction of new products, implementation of clinical trials, continued conformance of products to regulatory requirements, and compliance of corporate activities and functions with applicable and appropriate foreign and domestic regulations. The Vice President is also responsible for establishing the Company’s Regulatory Compliance program. This role reports to the CEO.
Duties and Responsibilities
· Strong ability to establish credibility with a broad range of constituents inside and outside of the company
· Creative problem-solving ability and willingness to take risks and act decisively while communicating potential consequences to ensure that informed business decisions are made
· Self-confident and willing to defend beliefs while maintaining flexibility
· Passionate, results-oriented executive who thrives in dynamic and challenging business cultures
· Proven track record of success in initiating and completing PMA clinical trials for Class III devices
· Demonstrated ability to implement standards, processes, and metrics that ensure Regulatory/GCP compliance in a balanced fashion
· Ability to collaborate with functional peers to assure that a robust clinical trials program is in place that will support a scientifically valid and compelling publication strategy
· Proven ability to earn the respect and acceptance of existing and future clinical investigators on a peer-to-peer basis
Hyalex values are focused on teamwork, communication, innovation, integrity, and accountability and all team members strive to promote an inspirational and productive workplace. Every team member’s contribution is valued as we work towards a common goal of transforming orthopaedics.
What we offer:
The health and safety of our team members is our primary concern, especially during the COVID-19 pandemic. Beyond compliance with all local, state and national requirements we have taken additional measures to support the safety of our on-site operations and personnel.
Important notice to Employment businesses/ Agencies
Hyalex does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact the Hyalex human resources department to obtain prior written authorization before referring any candidates. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Hyalex. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Hyalex. Hyalex shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.