Regulatory Affairs & Quality Assurance Manager, Swiss Dermatology

Stratpharma is seeking an experienced and dynamic Regulatory Affairs & Quality Assurance Manager to lead the regulatory and quality functions for our new Chinese subsidiary. The successful candidate will play a critical role in shaping the future of our international operations, ensuring compliance with global regulatory standards, and driving quality assurance initiatives to support our ambitious growth plans.

Requirements

• Minimum 5 years of experience in Regulatory Affairs and Quality Assurance, preferably within the Medical Device or Pharmaceutical industry.
• Proven track record in leading regulatory submissions and managing quality systems.
• Strong knowledge of ISO 13485, MDD, MDR, and other relevant regulatory standards.
• Familiarity with ISO 9001, ISO 13485, CE, and Chinese medical device regulations
• Excellent communication and interpersonal skills, with the ability to influence and collaborate with diverse stakeholders.
• Strong analytical and problem-solving skills, with a focus on continuous improvement.
• Bachelor’s degree in a relevant scientific or regulatory field; advanced degree preferred.
• Fluency in English; proficiency in additional languages is a plus.

Benefits

• leading salary with bonus and benefits