עדיין מחפשים עבודה במנועי חיפוש? הגיע הזמן להשתדרג!
במקום לעבור לבד על אלפי מודעות, Jobify מנתחת את קורות החיים שלך ומציגה לך רק משרות שבאמת מתאימות לך.
מעל 80,000 משרות • 4,000 חדשות ביום
חינם. בלי פרסומות. בלי אותיות קטנות.
מלאה
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.
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!!
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.
במקום לעבור לבד על אלפי מודעות, Jobify מנתחת את קורות החיים שלך ומציגה לך רק משרות שבאמת מתאימות לך.
מעל 80,000 משרות • 4,000 חדשות ביום
חינם. בלי פרסומות. בלי אותיות קטנות.
