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The Senior Regulatory Affairs Specialist is ideal for a regulatory professional ready to take the next step in their career and thrive in a dynamic, fast-paced environment. You will lead regulatory strategies and submissions for innovative medical devices, ensuring compliance with global requirements and supporting successful product approvals.
Reporting to the EVP of CMC, this individual will develop business for drug substance/CMC CDMO activities across the West Coast. Preferably based out of SF or SD, the Director is expected to meet clients and attend conferences/trade shows across respective biopharma hubs.
The Longevity Doctor will take initiative in designing and delivering transformative wellness experiences. Based in beautiful Cancún, you'll work alongside a multidisciplinary team to transform lives through personalized, science-backed health strategies in a welcoming resort-style clinical setting.
The Design Quality Engineer ensures that all medical device design and development activities meet safety, performance, and regulatory standards. This role partners with cross-functional teams to support new product development and sustaining engineering projects, driving quality, compliance, and risk management throughout the design lifecycle
The Quality Manager leads the company's Quality Systems in compliance with ISO 13485 and global medical device regulations, ensuring robust oversight of product release, CAPA, audits, and technical investigations. This role is critical in maintaining regulatory readiness and driving continuous improvement across the organization's quality operations.
The Senior Quality Engineer role focuses on leading quality assurance initiatives across manufacturing processes, ensuring compliance with industry standards and customer requirements. The position involves driving root cause analysis, corrective actions, and continuous improvement efforts to enhance product reliability and operational efficiency.
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