A well-established medical device company is seeking an experienced VP of Regulatory Affairs & Quality Assurance (RA/QA) to lead compliance, quality systems, and regulatory strategy.
This senior leadership position reports directly to the CEO, offering a key role in shaping the company's global compliance, product safety, and quality standards.
Key Responsibilities:
- Regulatory Compliance & Certification Ensure full compliance with ISO 13485, FDA QSR, CE MDR, and other global medical device regulations. Manage submissions, audits, and ongoing regulatory affairs processes.
- Quality System Leadership Oversee and optimize QMS, risk management, supplier quality, and post-market surveillance to maintain the highest product standards.
- Product & Process Oversight Drive quality control for design, manufacturing, labeling, and packaging, ensuring regulatory and clinical requirements are met.
- Strategic Alignment Collaborate with R&D, operations, and manufacturing teams to integrate compliance and quality into product development and production.
- Inspection & Audits Lead external and internal regulatory inspections, ensuring continuous compliance and audit readiness.
- Continuous Improvement Develop and implement efficiency-driven quality processes, and risk mitigation strategies.
- Team Leadership Manage and mentor a multidisciplinary RA/QA team, fostering a culture of quality excellence.
Requirements: Ideal Candidate:
- 10+ years of experience in RA/QA roles within medical devices (preferably dental, or Class II medical products).
- Deep expertise in regulatory submissions, compliance, and audits for FDA, CE, ISO 13485, and MDR.
- Proven experience in quality management, risk analysis, and supplier quality assurance.
- Strong leadership skills with the ability to collaborate cross-functionally with engineering, production, and regulatory bodies.
- Track record of successfully navigating regulatory approvals and maintaining QMS excellence.
- Excellent communication skills and ability to interact with regulatory agencies, auditors, and internal teams.
- Excellent English is a must (will be tested).
- Excellent communication and teamwork skills are required.
- Must be available for a global VP position that demands intensive work, often outside of regular office hours.
- On-site position!!
This position is open to all candidates.