Chief Development Officer

Sinclair Ltd — Netherlands · Posted ~8 hours ago

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Description

Location: Flexible across Europe (Preferred: Netherlands, UK, Germany, Italy, Spain or France) Role Purpose The Chief Development Officer (CDO) is a member of the Executive Leadership Team and is responsible for leading the Company's global Quality, Regulatory Affairs, Vigilance and Product Development functions. The role will ensure the organisation maintains the highest standards of product quality, patient safety, regulatory compliance and development excellence across its injectable aesthetics portfolio. A key priority will be strengthening regulatory compliance, audit readiness, product lifecycle management, post-market surveillance and quality systems, while supporting the development and commercialisation of innovative injectable products. The successful caliber will bring extensive leadership experience within the injectable aesthetics industry and a proven track record of managing Quality and Regulatory functions within highly regulated environments. Candidate Profile Candidates must possess substantial leadership experience within injectable aesthetics, dermal fillers, collagen stimulators, regenerative aesthetics, biostimulators or adjacent injectable product categories. The successful candidate will be recognised as a Quality and Regulatory leader first, with sufficient understanding of product development and innovation to oversee the product lifecycle, whilst ensuring regulatory compliance, patient safety and audit readiness remain at the centre of decision-making. The individual must have demonstrated experience leading organisations through regulatory remediation, audit preparation, MDR compliance and quality transformation programmes. Key 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. Qualifications & Experience – Essential • Bachelor's degree in Life Sciences, Biomedical Sciences, Pharmacy, Chemistry, Engineering or a 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. Highly Desirable • Previous leadership experience within aesthetics industry or similar injectable aesthetics organisations. • Experience supporting MDR transition programmes. • Experience leading quality and regulatory transformation within a mid-sized international business. • Experience working directly with Boards, Investors or Shareholders.