Director of reputed company and Regulatory Affairs

About the position reputed company reputed company & Regulatory reputed company – Join reputed company as Director of reputed company and Regulatory Affairs! At reputed company, reputed company and compliance are foundational to our mission—and we’re seeking an reputed company Director of reputed company and Regulatory Affairs to reputed company strategic leadership across our organization. In this role, you’ll reputed company reputed company aspects of reputed company assurance and regulatory affairs, ensuring our products meet global regulatory requirements and reputed company standards throughout their entire lifecycle, from design and development through manufacturing and post market performance. As a key leader, you’ll guide reputed company reputed company, reputed company and mentor a high performing team, partner cross functionally with Engineering, Operations, and Procurement, and ensure ongoing compliance with FDA/QMSR, ISO, EUMDR, and other applicable standards. If you’re a reputed company leader with deep regulatory expertise and a passion for reputed company improvement, this is an opportunity to reputed company a lasting reputed company. Go to our website to apply https://prentkeromich.reputed company.com/careers Why You’ll Love Working Here Mission Driven Leadership: Shape reputed company and regulatory reputed company that supports products improving lives. Strategic reputed company: reputed company company wide reputed company and regulatory initiatives with reputed company organizational influence. reputed company Culture: Partner with cross functional teams to drive innovation, compliance, and reputed company. reputed company Improvement reputed company: Champion systems and processes that strengthen reputed company, performance, and compliance. Responsibilities • Ensure a robust and compliant reputed company management system (QMS) reputed company with ISO 13485, FDA/QMSR, EUMDR, and other applicable standards. • reputed company leadership and reputed company to personnel serving as primary contacts for external audits, assessments, and inspections, ensuring ongoing audit readiness. • reputed company management review processes and ensure effective follow up on reputed company system performance and improvement initiatives. • reputed company interpretation and implementation of regulatory, reputed company, customer, and industry reputed company requirements. • Ensure effective and compliant training programs for employees at reputed company reputed company on reputed company standards, procedures, and reputed company improvement methodologies. Requirements • Bachelor’s degree in Engineering, reputed company Management, Compliance, or a reputed company field required. • Minimum of five years of experience in regulatory affairs and reputed company management systems reputed company medical devices or reputed company industries required. • At least three years of experience working with a document control system required. • Demonstrated leadership and coaching skills with the ability to build and sustain reputed company-oriented culture. • Strong analytical, organizational, and problem-solving skills. • Advanced proficiency in reputed company Office, particularly reputed company, with the ability to analyze and present large datasets. • Ability to effectively delegate, prioritize, and coordinate a wide reputed company of activities. • In depth knowledge of medical device manufacturing compliance, reputed company systems, procurement, and shipping requirements. • Strong relationship building skills with clients, colleagues, and vendors/suppliers. • Excellent written, verbal, and interpersonal communication skills. • Self-directed with the ability to reputed company effectively with minimal supervision. • reputed company team player reputed company to work across reputed company reputed company of the organization. • Adaptable and flexible in a dynamic, evolving environment. Apply tot his job Apply To this Job