Job Description

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:

• Lead the preparation, submission, and management of PMA and IDE applications, ensuring meticulous attention to detail and adherence to timelines.
• Provide strategic input into clinical trial design and execution, ensuring alignment with regulatory requirements.

QMS Excellence:

• Oversee the development, implementation, and maintenance of a robust QMS compliant with 21 CFR Part 820, ISO 13485, and other relevant standards.
• Lead internal and external audits, including FDA inspections and Notified Body audits, ensuring successful outcomes.
• Drive continuous improvement initiatives to enhance the effectiveness of the QMS.

Team Leadership & Collaboration:

• Lead and mentor a high-performing RA/QA team, fostering a culture of excellence and collaboration.
• Collaborate with cross-functional teams (R&D, Clinical, Manufacturing, Marketing) to ensure seamless regulatory and quality integration.
• Act as the management representative for the quality system.

Ideal Candidate Profile:

• Bachelor's degree in a scientific or engineering discipline (advanced degree preferred).
• 10+ years of progressive experience in RA/QA within the medical device industry, with a strong emphasis on Class III devices.
• Proven track record of successfully leading PMA and IDE submissions.
• Extensive knowledge of FDA regulations (21 CFR Part 820), ISO 13485, and other relevant standards.
• Strong leadership, communication, and interpersonal skills.
• Strategic thinker with exceptional problem-solving and analytical abilities.
• Experience with risk management according to ISO 14971.
• Experience leading and managing regulatory interactions with the FDA.
• Cardiovascular medical device, specifically stent experience is a strong plus.

Job Tags

Similar Jobs