Vice President Regulatory Affairs Quality Assurance
Listed on 2026-02-01
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Quality Assurance - QA/QC
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Healthcare
VP of Quality Assurance & Regulatory Affairs Permanent Position Competitive Salary & Benefits
About the company:
An mid-size Med Tech company specializing in Class II and III Vascular products.
The QARA function has an established team with good staff retention, and now needs an experienced VP of Regulatory Affairs and Quality Assurance to lead these functions.
Position Overview:They are seeking a strong Class III background with demonstrable experience of leading both Regulatory Affairs and Quality Assurance teams as they develop and take to market new devices.
You will be responsible for developing and implementing regulatory strategies, ensuring compliance with global regulations, and ensuring Quality standards and compliance throughout the organization.
You'll also support their continued growth by playing a key role in hiring further QARA resource, as they expand into new territories with their growing portfolio.
Key Responsibilities:- Regulatory Strategy: 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.
- Regulatory Documentation: Prepare and review regulatory submissions, including pre-market submissions and technical documentation.
- Quality Assurance: Ensure Quality assurance and compliance across the site. Lead internal and external audits as necessary.
- 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.
- Join a growing Medtech with a growing portfolio, working on key projects over the next 5 years.
- Make a meaningful impact on patient care and healthcare efficiency.
- Collaborate with an expert leadership team in a dynamic work environment.
- Competitive salary and benefits package.
To apply, please submit you’re an up to date resume. We look forward to reviewing your application.
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