(Sr.) RA Specialist (Medical Devices)

An organisation in Taiwan seeks a Senior Regulatory Affairs Specialist to ensure regulatory compliance and support the launch of innovative healthcare technologies.

Key responsibilities:

As a Senior Regulatory Affairs Specialist, you will manage product registrations, ensure regulatory compliance, support cross-functional projects, and maintain accurate documentation across the product lifecycle.

Regulatory Affairs & Product Registration

• Lead product registrations, renewals, amendments, and maintenance activities across the product lifecycle
• Prepare, review, and submit regulatory documentation in compliance with local medical device regulations
• Assess product changes, develop regulatory strategies, and support timely approvals for new and existing products
• Collaborate with regulatory authorities and cross-functional teams on submissions, compliance matters, audits, and process improvements
• Maintain regulatory records, databases, labelling, and documentation in alignment with SOPs, quality systems, and local requirements

Regulatory Intelligence & Compliance

• Monitor regulatory developments and assess potential business and compliance impacts
• Collaborate with industry groups and stakeholders on regulatory and compliance matters
• Review marketing and promotional materials for regulatory compliance
• Support timely implementation of regulatory updates and compliance actions

Quality & Audit Support

• Represent regulatory affairs during internal and external audits
• Support audit readiness, corrective actions, and closure of regulatory findings

Candidate profile:

To excel in this role, you bring medical device regulatory affairs experience, strong bilingual communication skills, and the ability to manage complex submissions accurately.

• Strong knowledge of Taiwan medical device regulations and quality management systems, including ISO 13485
• 8–10 years’ regulatory affairs experience within the medical device or healthcare industry preferred
• Proven experience preparing, reviewing, and managing regulatory submissions and technical documentation
• Strong strategic thinking, problem-solving, and project management capabilities
• Excellent communication and interpersonal skills with the ability to collaborate across functions
• High level of accountability, ownership, and attention to detail
• Bachelor’s degree or above in Life Sciences, Engineering, Medical Technology, Pharmacy, Biology, or a related field, with relevant regulatory or compliance training preferred

Keywords: regulatory affairs, healthcare technologies, product registrations, product lifecycle, documentation management, medical devices

What’s next:

Apply now to advance your regulatory affairs career within the medical devices industry!