Join a high energy team of leading experts in the medical device industry!
* Provide strategic and operational support to the VP, Regulatory to achieve agreed-upon regulatory and corporate objectives.
* The Director will be responsible for Clinical Trials Management, Provide oversight over Doctor's research and FDA Filings
* Support surgeons and investigators in data analyses, case proctoring, Phase I, iii, & IV studies, Regulatory Compliance.
* Manage performance for clinical development activities, study design, protocol development.
* Participate in key IDE activities, FDA interactions/submissions, PMA submissions, data reviews, and analysis.
Advanced Degree in life sciences and/or Biology
5 – 10 + years’ experience in clinical trial management in a medical device company
Expertise in the FDA and international regulations and guidelines and knowledge of regulatory submissions
Experience in strategic planning and collaboration across multiple functions within a company
Progressive & proven record of delivering results on behalf of regulatory departments within a medical device company and experience establishing long term strategic growth initiatives.
Experience with all phases of manufacturing and product development lifecycle, including concept, design, implementation, verification and validation activities necessary for product commercialization
High level of personal and professional integrity and trustworthiness with a strong work ethic and the ability to work independently with minimal direction
Excellent communication skills: Written, verbal, and interpersonal
General computer skills including Microsoft Office products (Word, Excel, Project)
Performs other duties as assigned
Additional Salary Information: The compensation package is created per individual based on skills and experience.
We offer lucrative Corporate Stock Options valued at 250K - 300K.
Internal Number: 1
About ACCI Search
ACCI is recruiting for a medical device company headquartered on the northside of Atlanta with products used for wound irrigation and debridement. The mission of the company is to reduce infections, reduce healthcare costs, and improve patient outcomes.