Title: Vice President of Quality Assurance and Regulatory Affairs (Medical Devices)
Job Description: We are seeking an accomplished Vice President of Quality Assurance and Regulatory Affairs with extensive experience in 510(k) filings, PMA (Pre-Market Approval) product submissions, and IDE (Investigational Device Exemption) trials within the medical device industry. As a crucial member of our executive team, you will drive the strategic direction of quality assurance and regulatory compliance to ensure the successful market approval and compliance of our medical device portfolio.
Responsibilities:
Regulatory Strategy and Compliance:
- Develop and execute comprehensive regulatory strategies to facilitate successful 510(k) filings, PMA submissions, and IDE trials, aligning with organizational objectives and regulatory requirements.
- Oversee compliance with FDA regulations, international standards, and applicable guidelines to maintain product approvals and market access.
Quality Assurance Leadership:
- Establish and maintain a robust Quality Management System (QMS) to ensure product quality, safety, and efficacy throughout the product lifecycle.
- Drive continuous improvement initiatives and cultivate a culture of quality excellence, emphasizing adherence to industry best practices and evolving regulatory expectations.
Product Development Support:
- Collaborate closely with cross-functional teams, providing regulatory guidance and expertise to ensure alignment with regulatory requirements during product development stages.
FDA Interactions and Submissions:
- Lead engagements with the FDA and other regulatory authorities, representing the company's interests, facilitating successful submissions, and navigating the regulatory approval process effectively.
Clinical and Regulatory Affairs:
- Oversee the planning, execution, and management of IDE trials, ensuring adherence to regulatory protocols and efficient study conduct.
- Manage post-market surveillance activities, adverse event reporting, and other regulatory reporting requirements.
Qualifications:
- Bachelor's or advanced degree in a relevant field (e.g., Life Sciences, Engineering, Regulatory Affairs).
- 15+ years of experience in medical device industry in QA/RA, demonstrating successful 510(k) filings, PMA product submissions, and IDE trials.
- In-depth knowledge of FDA regulations and guidelines pertaining to medical devices.
- Strong leadership skills, strategic planning capabilities, and exceptional project management abilities.
- Excellent communication and interpersonal skills, essential for effective collaboration with internal teams and interactions with regulatory authorities.
Join us in leading the way in the medical device industry, leveraging your expertise to drive quality assurance and regulatory compliance, ensuring the timely approval and market success of innovative medical devices that impact the lives of patients positively.
*this role is onsite and requires someone who is willing and able to be fully onsite
