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 to support 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 President and CEO.

DUTIES AND RESPONSIBILITIES

• Develop and implement regulatory and clinical strategies that leverage the Company's unique technology
• Author and submit the Company's regulatory submissions to the Food and Drug Administration and other regulatory bodies and governmental agencies 
• Hire and manage Clinical and Regulatory staff to execute the tactical aspects of each functional area
• Review and provide input into the design of the Company's pre-clinical testing in accordance with regulatory requirements
• Design the Company's clinical trials, in concert with the Surgeon advisors
• Develop and maintain a productive and collaborative relationship with the Orthopaedics Branch of the FDA and other governmental regulatory agencies
• Provide counsel and work collaboratively with outside consultants and external vendors to ensure timely and accurate collection and reporting of human clinical results
• Evaluate and recruit U.S. and international investigators for clinical studies 
• Establish relationships with physicians, Clinical Research Organizations (CROs) and clinical sites to contract and conduct trials
• Ensure compliance with clinical protocols by establishing and overseeing procedures that require active monitoring of clinical sites.  Review all data submitted for consistency and completeness
• Travel to Clinical sites and meet with key investigators
• Providing proof of full COVID-19 vaccination status. While the Company will consider accommodations for disability- and religious- based reasons, vaccination is generally considered a necessary attribute of the position.
• Provide guidance to all functional areas of the Company to achieve ISO certification and pass FDA GMP inspections
• Other duties as requested

QUALIFICATIONS/WORK EXPERIENCE

• Bachelors, Masters or PhD with 10 – 15 years of employment in the medical device industry, with at least 5 years in Class II/III implantable orthopedics devices
• Experience obtaining domestic regulatory approvals (510(k), IDE, PMA) as well as meeting worldwide regulatory requirements, including CE and ISO regulatory requirements, individual country registrations, etc.
• Successful history of managing the clinical and regulatory areas of the product development process from conception to approval
• Thorough understanding of all relevant regulations including IDE, PMA, GLP, GCP and GMP with a good working knowledge of data reporting and field monitoring 
• Experience identifying, hiring and developing a staff to support clinical monitoring and data management for IDE studies, including CROs
• Successful history with FDA and ISO facility audits
• Established ability to build, manage, and lead teams while providing dependable leadership in a variety of business climates
• 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

WHY HYALEX?

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:

• Competitive compensation and generous stock options
• Comprehensive medical, dental and vision benefits
• Pre-tax savings plans for healthcare
• 401(k) retirement plan
• Generous paid time off (PTO)
• Short-term and long-term disability insurance and an employee assistance program
• Life and AD&D insurance
• Tuition reimbursement
• Paid parental leave
• The opportunity to work with driven and enthusiastic colleagues in a fast-paced and entrepreneurial environment, on problems that matter in a highly collaborative environment

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.