Interacts with and may manage Regulatory consulting resources
Assist in developing and directly implements strategies for earliest possible approvals of applications
Ensures timely preparation of organized and scientifically valid applications
Provides expertise in translating regulatory requirements into practical, workable plans.
Assures that the company complies with the applicable regulatory requirements and standards for the development, pre-clinical and clinical evaluation, manufacturing, and marketing of its products in the US
Participates in the interaction, negotiations, and reporting with regulatory agencies (i.e. CDRH, CDER, etc.)
Actively participates in and potentially manages or monitors complaint handling and/or vigilance reporting
Maintains regulatory procedures and documents to maintain approvals and certification for development, manufacturing, and marketing of products
Informs senior management of regulatory requirements and status of products and significant regulatory issues/trends
Has responsibility for planning and implementing regulatory budget
May work as an independent contributor
Assists others within the Regulatory department with activities as requested
Performs other duties as necessary
Minimum BS in Life Sciences, advanced degree preferred with a least 5 - 7 years of experience working within the medical device/pharmaceutical products regulatory environment, specifically FDA.
Significant experience working with FDA Class III medical device and pharmaceutical regulations. In addition, experience within other international markets is a plus.
Experience in providing regulatory direction to development, pre-clinical and clinical evaluation, manufacturing, and marketing of combination products, including experience with CMC requirements, specifically with high risk devices (Class III; IDE through PMA)
Experience in independently preparing all required documentation and submissions and obtaining approval of device/drug combination product FDA submissions and follow-up maintenance activities for approvals
Established positive and productive relationships with representatives of regulatory bodies
Significant experience planning for and management of regulatory compliance audits
Demonstrated strong communication, negotiation, and management skills
Ability to travel in the US up to 10%
Employer will assist with relocation costs.
Internal Number: 01292018
About Micell Technologies
Micell Technologies is bringing together the clinical advantages of a drug-eluting stent with the long-term safety and stability of a bare metal stent. The resulting drug-delivery device is intended to redefine the field of interventional cardiology.