What are the responsibilities and job description for the Vice President Regulatory Affairs Quality Assurance position at BioTalent?
Our Client : A rapidly expanding medical device start-up in Class III stent technology, dedicated to revolutionizing patient care.
Location : Houston, TX
About Our Client :
We're representing a dynamic and forward-thinking medical device company at the forefront of Class III stent development. Our client is committed to delivering groundbreaking solutions that improve patient outcomes. They are seeking a highly accomplished and strategic Sr. Director / VP of Regulatory Affairs & Quality Assurance (RA / QA) to spearhead their regulatory and quality initiatives, with a critical focus on driving PMA and IDE submissions and bolstering their robust Quality Management System (QMS).
The Opportunity :
This is a pivotal leadership role for a seasoned RA / QA professional to make a significant impact on a company poised for substantial growth. You will be instrumental in navigating the complex regulatory landscape for Class III medical devices, ensuring timely product approvals and maintaining the highest standards of quality. This role offers the chance to lead a talented team and collaborate with cross-functional partners to bring life-changing technologies to market.
Key Responsibilities
Strategic Regulatory Leadership :
- Develop and implement comprehensive regulatory strategies for Class III stent products, driving successful PMA and IDE submissions.
- Serve as the primary liaison with regulatory agencies (FDA, Notified Bodies), managing interactions and ensuring compliance.
- Provide expert guidance on evolving regulatory requirements and industry best practices.
PMA & IDE Mastery :
QMS Excellence :
Team Leadership & Collaboration :
Ideal Candidate Profile :
