Job Description:
This Exclusive mandate seeks a highly experienced and motivated Global Head of Quality and Regulatory with direct leadership expertise and hands on mentality to join a dynamic client in the medical device field. This leadership role is critical in ensuring our products meet the highest standards of quality and regulatory compliance across all markets.
Key Responsibilities:
- Leadership and Strategy: Develop and implement global quality and regulatory strategies to ensure compliance with international standards and regulations.
- Regulatory Compliance: Oversee the preparation and submission of regulatory filings, ensuring timely approvals for new products and maintaining compliance for existing products.
- Quality Management: Lead the development, implementation, and maintenance of the Quality Management System (QMS) in accordance with ISO 13485 and other relevant standards.
- Risk Management: Ensure robust risk management processes are in place, including risk assessments, CAPAs, and continuous improvement initiatives.
- Team Management: Lead and mentor a global team of quality and regulatory professionals, fostering a culture of excellence and continuous improvement.
- Stakeholder Collaboration: Collaborate with cross-functional teams, including R&D, manufacturing, and marketing, to ensure quality and regulatory requirements are integrated into product development and lifecycle management.
- Audits and Inspections: Manage internal and external audits, including those conducted by regulatory bodies, and ensure timely resolution of any findings.
- Regulatory Intelligence: Stay abreast of global regulatory changes and trends, and proactively adjust strategies to maintain compliance and competitive advantage.
Qualifications:
- Education: Advanced degree in a relevant field such as biomedical engineering, regulatory affairs, or a related discipline.
- Experience: Minimum of 8 years of experience in quality and regulatory roles within the medical device industry, with at least 5 years in a senior leadership position.
- Knowledge: In-depth knowledge of global regulatory requirements, including FDA, EMA, and other international regulatory bodies.
- Skills: Strong leadership and team management skills, excellent communication and interpersonal skills, and the ability to work effectively in a fast-paced, dynamic environment.
- Certifications: Relevant certifications such as RAC (Regulatory Affairs Certification) or CQE (Certified Quality Engineer) are highly desirable.
- Travel: Willingness to travel internationally as required.
What We Offer:
- Innovative Environment: Be part of a leading medical device company that is at the forefront of innovation.
- Professional Growth: Opportunities for continuous learning and professional development.
- Competitive Compensation: Attractive salary and benefits package.
- Work-Life Balance: Flexible working hours and the possibility of remote work arrangements.
- Supportive Culture: A collaborative and inclusive work environment that values diversity and teamwork.
- Company Car
