Connect Life Science ยท 1 day ago
Vice President Regulatory Affairs Quality Assurance
California, United States
Full-time
Hybrid
Director/Executive
$250K/yr - $300K/yr
10+ years expConnect Life Science is a mid-size MedTech company specializing in Class II and III Vascular products. They are seeking an experienced VP of Regulatory Affairs and Quality Assurance to lead these functions, develop regulatory strategies, ensure compliance with global regulations, and oversee quality standards throughout the organization.
Staffing & Recruiting
Hiring Manager
David Clifton
Responsibilities
Develop and execute comprehensive regulatory strategies for class II and III products, keeping abreast of evolving US and Global regulations and industry trends to ensure market access and compliance
Prepare and review regulatory submissions, including pre-market submissions and technical documentation
Ensure Quality assurance and compliance across the site. Lead internal and external audits as necessary
Qualification
Required
Bachelor's degree in a relevant field (Engineering, Life Science, Quality/Regulatory etc.)
10+ years of QA and/or regulatory affairs experience in the medical device industry, with proven experience in cardiovascular, endovascular, neuro or similar
Strong knowledge of FDA regulations, EU MDR, and other global regulatory requirements
Proven track record of successful regulatory submissions and approvals
Experience with risk management processes and quality systems (ISO 13485)
Previously hired and/or developed strong QARA teams
Ability to adapt to a fast-paced, dynamic environment
Benefits
Competitive Salary & Benefits
Competitive salary and benefits package.
Company
Connect Life Science
We are a highly specialised Life Science recruitment consultancy, partnering exclusively with the best talent in the industry and ensuring businesses deliver on their projects, with the goal to improve patient lives everywhere.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase