Medical Device _ RA Manager

Location 信義區 / Xinyi District
台北市 / Taipei City

Job type 正職 / Permanent

Remote Job available

Salary to

Category Product Management > Project Manager

Play a pivotal role in regulatory compliance and product safety, ensuring the company meets the highest standards across markets.
In-depth knowledge of ISO 13485, QMS, QSD and relevant medical device regulations, ensuring compliance at all stages of the product life cycle.
Work for a leading medical device company with global reach and a commitment to innovation and quality.

Client Description

A leading medical device company known for its commitment to innovation, quality, and patient safety. The company operates on a global scale and maintains a strong presence in various international markets.

Responsibilities

Ensure compliance with FDA, CE, ISO 13485, and other regulatory standards for Class II and III medical devices.
Prepare and submit regulatory documents for product registrations and approvals across international markets.
Monitor and interpret regulatory changes, ensuring that products maintain ongoing compliance.
Conduct internal regulatory audits to assess adherence to Quality Management System (QMS) and regulatory requirements.
Collaborate with cross-functional teams (e.g., Product Development, Quality Assurance) to ensure regulatory requirements are met throughout the product lifecycle.
Provide regulatory training and guidance to staff and stakeholders, ensuring awareness of relevant regulations.

Experience

5+ years of experience in Regulatory Affairs within the medical device industry
Fluent in English
Experience in regulatory submissions for Class II and III medical devices
Familiar with ISO 13485 and Quality Management Systems (QMS)、QSD

Education

Bachelor’s degree or higher in Life Sciences, Engineering, or a related field.
Additional certifications or training in Regulatory Affairs or Quality Management Systems are a plus.