Global Director of Quality, Regulatory & Product Development

Sinclair

Amsterdam

Hybrid

EUR 200,000 - 320,000

Full time

12 days ago

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Job summary

Sinclair in Europe is seeking a Chief Development Officer to lead global Quality, Regulatory, Vigilance and Product Development for injectable aesthetics. You will drive regulatory strategy, QMS, audit readiness and lifecycle management across our portfolio.

You will partner with Manufacturing, Supply Chain and Commercial teams, report to the Executive Team, and guide transformational quality initiatives to ensure patient safety and regulatory compliance.

Qualifications

  • Bachelor's degree in Life Sciences or related field.
  • Minimum 15 years in aesthetics/pharmaceuticals.
  • Minimum 10 years leadership in QA and regulatory affairs.
  • Deep knowledge of EU MDR, ISO 13485 and post-market surveillance.
  • Proven experience with external audits and Notified Bodies.

Responsibilities

  • Provide executive leadership for the global QMS.
  • Ensure compliance with ISO 13485, EU MDR, MDSAP and global requirements.
  • Lead audit readiness and remediation programmes.
  • Oversee CAPA, supplier quality and risk management.
  • Develop regulatory strategies and submissions globally.
  • Lead product registrations and lifecycle management.
  • Collaborate with Notified Bodies and authorities.
  • Oversee vigilance and post-market surveillance.
  • Guide product development aligned with quality and regulatory needs.
  • Partner with Manufacturing, Supply Chain and Commercial teams.
  • Update the Exec Team and Board on priorities.

Skills

Quality Assurance
Regulatory Affairs
Audit Readiness
QMS Leadership
Product Development
Cross-Functional Leadership
Regulatory Submissions

Education

Bachelor's degree in Life Sciences or related
15+ years in aesthetics/pharma
10+ years leadership in QA/RA

Job description

Sinclair in Europe is seeking a Chief Development Officer to lead global Quality, Regulatory, Vigilance and Product Development for injectable aesthetics. You will drive regulatory strategy, QMS, audit readiness and lifecycle management across our portfolio.

You will partner with Manufacturing, Supply Chain and Commercial teams, report to the Executive Team, and guide transformational quality initiatives to ensure patient safety and regulatory compliance.

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