Quality & Regulatory Associate, Challenging Global Role, Basel

vor 1 Woche


Basel, Basel-Stadt, Schweiz Stratpharma AG Vollzeit

An innovative Dermatology company located in the heart of Basel is offering a fantastic opportunity for a QARA Associate to collaborate closely with the International QARA Director in overseeing global QA and RA functions.

This thriving company has achieved remarkable 200% year-over-year growth and is currently undergoing substantial expansion. With 8 products already on the market and an additional 5 in the pipeline, including one set for release early next year.

Responsibilities:

  • Creation, compliance, and implementation of SOPs, Work Instructions, Non-Conformities, Change Control, CAPA, Artworks, and other related documents/tasks.
  • Maintenance and updating of all company documents.
  • Support for Internal and External Audits.
  • Initiation and review of regulatory documents, providing assistance to the Regulatory Manager during the MDD to MDR transition.
  • Coordinating global registrations and preparing regulatory submissions, along with necessary legalization activities.
  • Engagement with local agents and distributors to aid in their registration processes.
  • Keeping regulatory records and the regulatory database up to date.

Requirements:

  • Minimum of 3 years' experience in a similar position.
  • Solid understanding of regulatory standards and Quality Systems, including familiarity with ISO13485, MDD, MDR, and MDSAP requirements related to QMS activities.
  • Background in the Medical Device or Pharmaceutical sector.
  • Self-motivated individual capable of working independently.
  • Excellent communication skills for effective interaction with stakeholders, suppliers, and distributors.
  • Proficiency in both written and spoken English is mandatory, Spanish proficiency is advantageous.

Benefits:



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