Senior Regulatory Compliance Manager - Medical Devices/Pharmaceuticals/Healthcare - Asia Pacific

- Degree or Post graduate degree in Science, Pharmacy or Engineering or related field is required

- 5+ years of experience in the ISO 13485/Health Authority-regulated industry (medical devices or pharmaceuticals/Health Care), including at least few years of experience in Quality Assurance or Regulatory Compliance functions and management roles

- Detailed knowledge of medical devices regulatory requirements of the region is necessary.

- Experience in performing GxP / GMP audits and/or support of medical devices manufacturing sites is required.

- Experience in managing multiple aspects of Regulatory Compliance in an international/global context and a regulated healthcare environment.

- Experience in implementing regulatory requirements /regulatory changes such as Medical Device Regulations in a manufacturing set-up, to ensure Compliance, will be an advantage

- Lead Auditor Certification is preferred.

- Must have experience in manufacturing site environment (in Quality, Regulatory Compliance or Operations).

- Expertise on/detailed knowledge of regulatory requirements in the FDA/ISO/Health Authority-regulated industry (medical devices or pharmaceutical/consumer goods), with the ability to relate them to business/quality issues.

- Excellent written and oral communication skills, ability to quickly build credibility within the Quality and Compliance community, executive management, external regulators, and industry. Strong presentation skills.

- Strong collaboration and influence skills to partner effectively with other functions and across Operating Units. Proven track record of demonstrating collaboration across the organization and at all levels.

- Strong analytical skills. Balanced technical understanding of products and processes combined with superior business and compliance acumen.

- Ability to make decisions which will effectively support the business and company policies.

- Strong change/project management skills.