Regenesis Biomedical is developing next generation therapeutic devices for persistent post-operative pain and inflammation and a new focus on Peripheral Neuropathy and Painful Diabetic Peripheral Neuropathy (PDPN). We are dedicated to making a difference in the lives of patients and their families who bravely face these difficult healthcare challenges every day. This is a unique opportunity to be a major contributor to the success of a well-positioned, private equity owned, growth stage medical device company. This position is located in Scottsdale, AZ. Recently the Regenesis Board of Directors has determined the need to recruit a Vice President, Clinical Research and Regulatory Affairs, to report into Mr. Brooks. This is a unique opportunity to be a major contributor to the success of a well-positioned, private equity owned growth stage medical device company.
The Vice President of Clinical Research and Regulatory Affairs (VP-CRRA) will be responsible for overall leadership of the clinical research and regulatory groups. The VP-CRRA will develop and execute strategic clinical direction and clinical development activities of Pulsed Electromagnetic Field therapy (PEMF) products and programs. Key clinical activities will include protocol development, IRB submission, study support, clinical data base development and including clinical study report authoring. The VP-CRMA will provide scientific expertise to investigators, study teams and vendors and insure that clinical trials for products follow regulatory and medical requirements. The incumbent will be responsible for strategizing and satisfying regulation requirements to obtain regulatory clearance to market in the US, plus the EU and other countries in the future. The incumbent will work with engineers to determine testing and regulation standards that must be adhered to as products near commercialization. They will also support the quality department in ensuring that the company’s standard operating procedures meet the necessary regulations and that they are being followed. The VP-CRRA will plan and execute regulatory submissions necessary for clinical studies and be the regulatory strategist in terms of strategizing for business development plans and budgets. Along with the CEO, and other members of the Leadership Team, the VP-CRRA will represent Regenesis Biomedical externally with key stakeholders.
ESSENTIAL DUTIES & RESPONSIBILITIES
Conduct clinical studies, clinical trials, data analysis and data interpretation required for product introduction, marketing and label expansion.
Provide oversight and when necessary lead in taking innovative ideas from proof of concept through regulatory strategy, including filing and approval.
Responsible for the management of all clinical research and regulatory personnel.
Review and approval of scientific data supporting products and product labeling.
Ensure clinical development programs meet quality and safety standards required by medical and regulatory agencies.
Insure effectiveness and integrity to all regulatory filings.
Maintain outstanding relationships with all key internal customers and regulatory agencies. Interact with the FDA (and international regulatory agencies) on a proactive, independent and frequent basis.
Interface with our product development team to help define target product profiles and successfully translate those into clinical development.
Strengthen clinical knowledge of staff and serve as a resource for clinical information to both staff and key initiatives.
Represent the Company with regulatory agencies for product reviews, label expansion or reimbursement coverage.
Remain current in all appropriate regulations and participate when possible in continuing education.
Have P&L and budgetary responsibility for clinical research development and regulatory activities, providing strategic input to the annual and long-range budgetary process.
KNOWLEDGE & SKILL REQUIREMENTS
Substantial clinical development and execution experience, handling multiple parallel programs.
Experience in either the pain management or treatment of peripheral neuropathy preferred.
Current medical device industry experience, people management, project management and budget management experience required.
Broad scientific, technical and regulatory understanding of most of the functions involved in the development of a Class II medical product.
A strong and credible expert reputation within the profession, FDA, and other Global Regulatory Institutions.
Experience designing and overseeing a clinical development program, with emphasis on human studies.
Knowledge of FDA regulations and guidelines and experience in interactions with FDA personnel is essential; experience with other health authority’s a plus.
Superb ability to work on teams and across partner organizations.
Flexible to work non-business hours and travel domestically and internationally.
Ability to make effective presentations on complex topics.
Possess excellent strategic planning skills, good judgment and strong decision making capabilities.
Effective leadership, people management, communication and problem solving skills.
Team builder management style who is willing to be “hands on”.
EDUCATION, EXPERIENCE & TRAINING REQUIRED
An undergraduate degree is required; a scientific or clinical degree is highly preferred.
An advanced degree in science or business is desired. Certification in Regulatory Affairs Professionals Society (RAPS) a plus.
A minimum of 10 years’ management experience in clinical research and regulatory affairs is necessary with a balanced combination of each preferred.
Multiple years of management experience leading clinical research development.
Skilled in interpreting and adapting scientific clinical information for practical application.
A proven track record of product approvals including a successful track record of project management including the establishment of milestones, design records and technical filings.
Prior publications demonstrating the ability to write clearly and accurately.
Experience in the development, conduct, and analysis of clinical trials.
Experience with regulatory submissions for medical devices preferred.
Experience in diabetic and peripheral neuropathy market development preferred.
Results-oriented work ethic and a positive, can-do attitude.
High personal values and ethical standards.
Ability to locate in Scottsdale, Arizona at the company headquarters.
This is a high growth, fast paced small organization. The ability to be productive and successful in an intense work environment is critical. Willingness and ability to travel domestically and internationally is required, and it is anticipated that this will be 30% of work time.
Regenesis offers a competitive pay and equity program, bonus plan, health insurance benefits, matching 401k and a generous paid time off plan.
Regenesis Biomedical is an Equal Opportunity Employer
Reasonable accommodations can be requested by contacting
the Regenesis Human Resources Dept. at ph# 800-970-4970.
Regenesis Biomedical is an Arizona based medical device company dedicated to improving human welfare through the research, design, manufacture, and sale of energy-based medical products and services that alleviate pain, restore health, and improve quality of life. As a company, we value dedication, innovation, integrity, respect, excellence, compassion and teamwork.