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
Seniority level Not Applicable
Employment type Full-time
Job function Quality Assurance and Manufacturing
Industries Medical Equipment Manufacturing
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