Quality & Regulatory Associate, Challenging Global Role, Basel

Stratpharma is seeking a dedicated Quality & Regulatory Associate to join our dynamic team in Basel. This challenging global role will provide the opportunity to work closely with the International QARA Director, overseeing the company's global Quality Assurance (QA) and Regulatory Affairs (RA) activities.

As a pivotal member of our rapidly growing organization, you'll contribute to our mission of delivering innovative dermatological products. With an impressive growth trajectory and multiple products already in development, this role is ideal for individuals looking to make a significant impact in a thriving company.

Key Responsibilities:

• Develop and maintain SOPs, Work Instructions, Non-Conformities, Change Control, and CAPA documents.
• Ensure compliance with regulatory requirements and maintain all documentation within the company's systems.
• Support both Internal and External Audits.
• Assist the Regulatory Manager with the transition from MDD to MDR, by initiating and reviewing regulatory documents.
• Coordinate global registration efforts and compile regulatory submissions, including necessary legalization activities.
• Collaborate with local agents and distributors to facilitate their registration processes.
• Maintain comprehensive regulatory records and databases.

• Minimum of 3 years’ experience in a similar role within the Medical Device or Pharmaceutical industry.
• In-depth knowledge of regulatory standards including ISO13485, MDD, MDR, and MDSAP.
• Proactive self-starter with the ability to work independently and effectively.
• Excellent communication skills for effective interaction with stakeholders, suppliers, and distributors.
• Fluency in English (written and spoken) is essential; proficiency in Spanish is a plus.

This is a newly created role in a rapidly growing company that offers career boosting global exposure. The company has a friendly family culture and maintains a high level of staff retention.

The successful candidate will gain a varied and challenging role with competitive salary and industry leading bonus (20% of salary). Apply today to avoid disappointment.