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 QA Expert for the Corporate Quality Management team in our Marousi premises.

As a Medical Device QA Expert, the ideal candidate will oversee and manage medical device and combination product manufacturing within the organization from a quality perspective. This position requires a deep understanding of medical device regulations, quality standards, and the ability to collaborate with cross-functional teams to ensure the successful integration of medical devices into pharmaceutical products and processes.

More particularly:

What you will do:

Oversee and maintain compliance with 21 CFR Part 820 Quality System, ISO 13485 Quality Standard, ICH Q9 Guidance for Industry – Quality Risk Management, 21 CFR 4 Regulation of Combination Products, SOR 98-282 Canadian Medical Device Regulation, ISO 14971 Risk Management Standard, MDR 2017/745/EU, MDSAP Support in preparation of documents related to notified body assessment. Review of DHF documents and technical file of devices during preparation phase. Participate in design transfer Maintenance of DHF documents after design transfer to manufacturing site Perform post market surveillance for commercial products Work in collaboration with legal team to prepare manufacturing and quality agreements with suppliers Oversight suppliers on routine basis to ensure compliance to quality and uninterrupted supply. Perform periodic and for-cause quality audits of supplier Actively participate in authority related inspection readiness for combination product Ensure compliance to cGMPs, GDPs, QSR and applicable company policies and standards. Lead Device quality team Work in close collaboration with cross function teams  Review and approve change control proposals, deviations, investigations and CAPAs related to medical devices