Global Head of Quality, Regulatory & Development

Sinclair; Chester; Hybrid; GBP 150,000 - 230,000; Full time

Job summary

Sinclair is seeking a Chief Development Officer to lead global Quality, Regulatory Affairs, Vigilance and Product Development for injectable aesthetics. The role steers regulatory compliance, audit readiness and post-market surveillance while overseeing lifecycle management and development of innovative products.

Ideal candidate has extensive leadership in injectable aesthetics and MDR/ISO13485 expertise. Based in a flexible across Europe capacity, the CDO will collaborate with Manufacturing,

Qualifications

• Bachelor's degree in Life Sciences, Biomedical Sciences, Pharmacy, Chemistry, Engineering or related discipline.
• Minimum 15 years' experience within the aesthetics, injectable, pharmaceutical or biologics industry.
• Minimum 10 years' leadership experience in Quality Assurance and Regulatory Affairs.
• Significant experience within injectable aesthetics products, including dermal fillers, collagen stimulators, regenerative aesthetics or similar injectable technologies.
• Deep knowledge of EU MDR, ISO 13485, Design Control, Clinical Evaluation and Post-Market Surveillance requirements.
• Proven experience leading external audits, Notified Body inspections and regulatory remediation programmes.
• Demonstrated experience managing product lifecycle activities for injectable products from development through commercialisation.
• Strong understanding of manufacturing quality systems applicable to sterile or injectable products.
• Experience leading global cross-functional teams and operating within international markets.

Responsibilities

• Provide executive leadership for the global Quality Management System (QMS).
• Ensure compliance with ISO 13485, EU MDR, MDSAP and applicable global regulatory requirements.
• Lead organisational audit readiness and remediation programmes.
• Oversee CAPA, supplier quality, complaint management, risk management and quality governance.
• Develop and execute global regulatory strategies supporting the injectable product portfolio.
• Lead regulatory submissions, product registrations and lifecycle management activities globally.
• Build and maintain strong relationships with Notified Bodies, Competent Authorities and external regulatory partners.
• Provide oversight of global vigilance, complaint handling and post-market surveillance activities.
• Ensure effective monitoring and reporting of adverse events and field safety actions.
• Lead Product Development and R&D teams to deliver commercially relevant and compliant innovation.
• Ensure development programmes are aligned with quality, regulatory and commercial requirements.
• Partner closely with Manufacturing, Supply Chain, Medical Affairs and Commercial leadership teams.
• Regularly update the Executive Team, Board and Shareholders on quality, regulatory and development priorities.

Skills

Leadership experience

Quality Assurance

Regulatory Affairs

EU MDR knowledge

Notified Body audits

Product lifecycle

Audit readiness

Post-market surveillance

Design Control

Global cross-functional teams

Education

Bachelor's degree in Life Sciences

Job description

Sinclair is seeking a Chief Development Officer to lead global Quality, Regulatory Affairs, Vigilance and Product Development for injectable aesthetics. The role steers regulatory compliance, audit readiness and post-market surveillance while overseeing lifecycle management and development of innovative products.

Ideal candidate has extensive leadership in injectable aesthetics and MDR/ISO13485 expertise. Based in a flexible across Europe capacity, the CDO will collaborate with Manufacturing,