Stratpharma is seeking an experienced and dynamic Regulatory Affairs & Quality Assurance Manager to lead the regulatory and quality functions for our new Chinese subsidiary. This is a stand alone role that will drive the company's regulatory strategy and ensure the quality of our innovative dermatological products.
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.
Key Responsibilities:
- Develop and execute Chinese regulatory strategies for product approvals and compliance in various markets.
- Lead the Quality Assurance function to establish and maintain quality systems aligned with ISO 13485 and regulatory requirements.
- Oversee product registration processes and submissions to regulatory agencies, ensuring timely approvals.
- Collaborate with cross-functional teams including R&D, marketing, and operations to ensure regulatory compliance and quality standards are met throughout the product lifecycle.
- Provide strategic guidance on regulatory changes and developments impacting the business.
- Manage relationships with external regulatory authorities and agencies.
- Drive continuous improvement initiatives in quality management systems and regulatory processes.
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
- Experience in a similar role with demonstrated ability to work with international teams and drive strategic initiatives.
- Experience of liaising with the Chinese authorities.
- 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
This is a rare opportunity to get in at the ground floor of Stratpharmas growth story in China and join an exciting company with continued expansion. The successful candidate shall be able to make the role their own and build their position with the company. This is a small to medium sized company with an excellent culture and a family environment feel. The client is offering a leading salary with bonus and benefits.
