Principal QRC Specialist

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Overview

Independently manages regulatory affairs activities in Taiwan, including product registrations, license and QSD maintenance, MDR transitions, and post-approval changes. Serves as a subject-matter expert for complex or high-risk regulatory matters, leads the resolution of significant regulatory issues, and contributes to regulatory process improvement and best practices. Provides expert regulatory guidance, assesses regulatory and product change impacts, and coordinates cross-functional activities to support timely approvals and ongoing compliance. Provides technical guidance to QRC colleagues and represents the SSU in assigned regional or global regulatory initiatives. Performs delegated management representative responsibilities when formally designated.

Job Responsibilities and Essential Duties

- Act as the management representative proxy, when formally designated, for GDP, ISO 9001, and ISO 13485 matters within the delegated scope and authority.

- Develop and implement registration strategies for assigned products, exercising independent professional judgment to align priorities with the QRC Manager, commercial teams across Business Areas (BAs), and global Regulatory Affairs teams. Escalate decisions beyond the assigned authority.

- Independently plan, execute, and monitor multiple complex regulatory projects, including product registrations, license and QSD maintenance, MDR transitions, and post-approval changes. Maintain timelines, milestones, and status records, coordinate cross-functional dependencies, and lead monthly cross-functional RA progress reviews with comprehensive visibility of overall RA project status.

- Prepare, review, coordinate, and submit regulatory applications and responses to authority questions, assessing supporting documentation for completeness and consistency. Serve as the regulatory contact for assigned submissions and independently manage follow-up and stakeholder input to support approvals within agreed timelines.

- Provide technical guidance to QRC colleagues and represent the SSU in assigned regional or global regulatory projects and initiatives.

- Monitor and interpret applicable regulations, standards, and regulatory guidance, assess regulatory and product-related technical changes, and provide expert guidance on complex or high-risk regulatory matters. Lead the resolution of significant regulatory issues within the assigned scope and contribute to regulatory process improvements and best practices.

- Manage regulatory controls in the SAP GTS block module, ensuring accurate linkage between registered material numbers and sales orders to prevent unnecessary order blocks while maintaining regulatory compliance.

- Plan, organize, and maintain RA data and related documentation, including master files, RIMsys records, submission documentation, product licenses, and communication records, ensuring accuracy, completeness, traceability, and accessibility in accordance with company procedures.

- Perform other related duties and reasonable changes in responsibilities as assigned by the QRC Manager or the company based on business needs, consistent with the role and applicable requirements.

Minimum Requirements

- Bachelor's degree or above in life sciences, biomedical engineering, or a related field.

- At least 6 years of regulatory affairs experience in the medical device industry.

- Strong knowledge of TFDA regulations and medical device registration requirements and processes in Taiwan.

- Demonstrated experience in independently managing regulatory submissions and complex regulatory projects.

- Strong written and verbal communication skills in both Mandarin and English

- Strong organizational and prioritization skills, with the ability to manage multiple projects independently.

Required Knowledge, Skills and Abilities

- Exercises sound independent judgment in selecting appropriate courses of action, considering regulatory risks, business impact, trade-offs, timing, and available resources.

- Demonstrates strong analytical and problem-solving skills to interpret regulatory requirements, assess impacts, and provide practical regulatory guidance.

- Demonstrates strong project management and prioritization skills to independently manage multiple complex regulatory activities and cross-functional dependencies.

- Possesses strong interpersonal and stakeholder management skills to collaborate effectively and influence cross-functional teams and local and global stakeholders.

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About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.