Quality and Regulatory Expert

vor 3 Wochen


Basel, Basel-Stadt, Schweiz Stratpharma AG Vollzeit

An esteemed pharmaceutical company based in Basel, Switzerland, is seeking a highly skilled Quality and Regulatory Associate to join their dynamic team. This exciting opportunity will allow the successful candidate to work closely with the International QARA Director in managing the company's global QA and RA functions.

With impressive year-on-year growth of 200%, this innovative company is expanding rapidly, boasting eight products on the market and five more in development. One of these upcoming products is set to launch early next year.

Key Responsibilities:

  • Develop, implement, and maintain SOPs, Work Instructions, Non-Conformities, Change Control, CAPA, Artworks, and related documents.
  • Maintain and update all documents within the company's system.
  • Provide support for internal and external audits.
  • Assist in regulatory document preparation (Technical File) and collaborate with the Regulatory Manager during the transition from MDD to MDR.
  • Cover worldwide registration and compile regulatory submissions, including legalization activities.
  • Liaise with local agents and distributors to facilitate their registration process.
  • Ensure accurate maintenance of regulatory records and databases.

Requirements:

  • At least three years of experience in a similar role.
  • Strong knowledge of regulatory regulations and Quality Systems, including ISO13485, MDD, MDR, and MDSAP requirements in relation to QMS activities.
  • Experience within the Medical Device or Pharmaceutical industry.
  • A proactive self-starter able to work independently.
  • Exceptional communication skills for effective stakeholder liaison.
  • Fluent written and spoken English essential; Spanish an advantage.

Compensation:

The estimated salary for this position ranges between $60,000 and $90,000 annually, depending on qualifications and experience. The package may also include additional benefits such as bonuses, health insurance, and professional development opportunities.



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