Medical Device Quality Principal

Founded in 1969, Pharmathen has grown to become one of the largest, vertically integrated developers of complex drug delivery technologies and is among the top 50 pharmaceutical research companies in Europe.

The company has one of the most extensive and advanced pipelines of long-acting injectables (LAI), sustained release and ophthalmic formulations.

Pharmathen’s highly diversified portfolio consists of over 90 commercialized products, which are produced in its US FDA and EU-approved manufacturing facilities in Greece, serving 250 customers and accessed by patients in more than 90 countries worldwide.

Pharmathen proudly employs more than 1,600 people from over 28 different nationalities, with 54% of its total workforce and 66% of its Research Operations Team being female. The company’s enduring success is attributed to a passion for creativity, strong ethics, and the dedication of its people, who share a commitment to the company's vision of making a difference in people’s lives.

Due to continuous growth and expansion, Pharmathen Pharmaceuticals offers a great opportunity for career development and is seeking to recruit a Medical Device Quality Principal to join our Corporate Quality Management department at our Marousi premises.

The “Medical Device Quality Principal” is a senior leadership role with enterprise-wide accountability for defining and driving the global quality strategy for medical devices and combination products. The role ensures regulatory compliance, enables business growth, and safeguards patient safety across the product lifecycle.

This position operates with full decision authority, strategic impact, and high external visibility, partnering closely with executive leadership and cross-functional teams across the organization.

More particularly:

What you’ll do:

• Own the enterprise Medical Device Quality Management System (QMS) and ensure global regulatory compliance (FDA, EU MDR, ISO 13485, ISO 14971, and other applicable frameworks)
• Provide end-to-end quality oversight across design, development, transfer, commercialization, and post-market activities
• Act as the ultimate decision authority for critical quality and compliance matters, including risk management, CAPAs, deviations, and change control
• Drive supplier quality strategy and oversight of critical external partners and CMOs
• Partner with R&D, Regulatory, Manufacturing, and Supply Chain to ensure quality is embedded across the value chain

The ideal candidate should have:

Minimum Qualifications:

• Advanced degree in Life Sciences, Engineering, Pharmacy, or a related scientific field

Minimum Experience:

• Extensive experience in medical device quality within a global regulated environment

Job-Specific Skills:

• Strong expertise in FDA, EU MDR, ISO 13485, and ISO 14971
• Proven leadership in global or enterprise-level roles
• Experience interacting with regulatory authorities and leading inspections

Benefits:

What you will gain:

• Involvement in a high-caliber, team-oriented and dynamic atmosphere

• Exposure to challenging business issues and practices
• Great opportunity to leverage and develop your business/scientific knowledge and skills

Join our team and experience the unique Pharmathen’s culture that gives you the opportunity to innovate, to make decisions, to achieve your own potential and to chart your own career.

Pharmathen is an equal opportunity employer. We welcome applications regardless of gender, race, age, religion, sexual orientation, and national origin.