VP Regulatory Affairs and Quality Assurance
Introduction
We are currently seeking a visionary and experienced VP of RA-QA to join a highly innovative and pioneering MedTech scale-up to ensure alignment between regulatory and quality objectives and company strategy.
In this key role, you will take charge of quality operations, compliance, and regulatory strategies across the organization, driving excellence and ensuring adherence to global standards.
As the VP of RA-QA you will be responsible for managing quality systems, overseeing regulatory compliance efforts, and developing innovative strategies to navigate the complex regulatory landscape. This will involve leading interactions with regulatory authorities and ensuring effective collaboration with cross-functional teams.
Your extensive experience and strong leadership skills will be essential as you guide the organization in meeting regulatory requirements and achieving quality excellence. You will play a crucial role in developing and implementing best practices, ensuring compliance with ISO 13485, EEC 93/42, 2017/745, and 21 CFR 820, and identifying opportunities for improvement.
In addition to your technical expertise, your communication skills will be vital in effectively conveying complex regulatory information and engaging stakeholders at all levels. A strategic mindset will be key in aligning regulatory strategies with broader business objectives. Your ability to make informed decisions and manage multiple projects simultaneously will contribute to your success in this role.
Desirable qualifications include a master’s degree in a technical or scientific field, experience in start-up/scale-up environments, and familiarity with global regulations beyond the core standards. Additionally, proficiency in multiple languages can be advantageous in interacting with international regulatory bodies and stakeholders.
At our organization, we prioritize putting people first, being results-driven, and fostering innovation. These core competencies guide our culture and shape our actions, regardless of seniority. We strongly encourage personal and professional development, offering opportunities for growth and continuous learning.
To apply for this exciting opportunity, please submit your comprehensive CV and a cover letter that highlights your relevant experience and addresses how you meet the required qualifications and competencies.