Director Quality Assurance Quality Control

Responsibilities

• Work closely alongside with company’s management team.
• Lead, manage, and implement quality and regulatory activities in developing and implementing regulatory premarket strategies and processes to gain product approvals worldwide.
• Manage the Quality assurance and RA team and be responsible for all quality and regulatory matters across the company activities.
• Develop QMS strategies, systems, and processes to ensure product development, manufacturing, and post-market activities comply with the regulatory requirements.
• Collaborate with senior management and all functional groups at all enterprise levels to drive a culture of Quality by conceiving, collaborating, and supporting the implementation of specific actions, processes, and behaviors that support such a culture.
• Act as a trusted advisor and business partner in balancing risk and opportunity and advise on strategic decision-making.
• Drive the regulatory submissions in compliance with the applicable international regulatory requirements.
• Liaise directly with FDA, CE, and other regulatory agencies, including the preparation and leading agency meetings.
• Oversee and participate in the writing, reviewing, editing, and compiling of regulatory submissions and quality documentation.
• Hands on work while providing support, mentorship, and guidance to the company
• Lead HTS’ external audits.

Requirements

• Bachelor’s degree in a related field.
• 7+ years of experience in the fields of Regulatory and Quality Assurance in the Medical Devices Industry.
• Minimum 3 years of management experience in Quality Assurance & Regulatory Affairs.
• Excellent knowledge of ISO 13485:2016, MDSAP, MDD, MDR.
• Experienced in regulatory submissions to FDA, CE, and MDSAP jurisdictions for class 2 or 3 products.
• English at a very high level – both written and verbal - Must (other languages - an advantage).
• Hands-on approach.
• Great attention to detail, and a result-driven approach.
• Excellent personal & communication skills, highly motivated.
• Team player.