Join a high energy team of leading experts in the medical device industry! A unique opportunity to operate as our Director with a career track leading to the Vice President of Regulatory as our rapid growth continues.
* Provide strategic and operational support to the VP, Regulatory to achieve agreed-upon regulatory and corporate objectives. The Director will be responsible for executing day-to-day regulatory functions and oversight arising out US law and the FDA’s implementation thereof as well as the law and implementing regulations in relevant foreign jurisdictions.
* Support, and when and where possible, coordinate and possibly lead regulatory submission efforts in the US and OUSA. The Director is to ensure data and other documentation presented in all submissions are presented concisely, in full, and that data supports the conclusions and addresses the associated risks. The Director will also interact and collaborate daily with other functions of the company, including quality, clinical, sales, and legal, to ensure regulatory compliance and for other purposes. The Director will be responsible for providing regulatory guidance and oversight of the quality management system, drafting and complying with Standard Operating Procedures, and constantly finding ways to improve the company’s regulatory compliance efforts in each jurisdiction in which company products are cleared/approved for sale and in each country in which the company may seek clearance/approval.
* Continued education to stay up-to-date with the latest regulatory developments that may impact the business and must have very strong research and writing skills.
The Director reports to the Vice President, Regulatory with the opportunity to become the Vice President of Regulatory when our current Vice President shifts focus to new initiatives.
Advanced Degree in life sciences and/or engineering
5 – 10 + years’ experience in regulatory in a medical device company
Regulatory Affairs Certification (RAC) preferred
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.