Regional Regulatory and Quality Assurance Associate

Regional Regulatory and Quality Assurance Associate

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Overview

We are looking for a highly motivated and experienced Regulatory and Quality Assurance Manager to join our medical team. This role will ensure regulatory compliance and execute robust quality assurance practices in both emerging and established markets across Asia Pacific. In this role, you will lead initiatives to navigate local and international regulations, driving product lifecycle success—from development and manufacturing through to distribution and post-market surveillance. As a key player in our regulatory affairs team, you'll work cross-functionally with global regulatory, quality assurance, and marketing teams to deliver timely product approvals, uphold our Quality Management System, and support market entry strategies. Ideal candidates are forward-thinkers with a passion for advancing healthcare solutions through compliance excellence. If you bring a results-driven mindset, strategic vision, and entrepreneurial energy, we invite you to make a meaningful impact on both our organization and the broader healthcare industry.

This role will be located at our facility in Singapore.

Responsibilities

• Work with product regulatory associates and other internal stakeholders to develop and execute regional regulatory strategies for medical devices, ensuring compliance with country-specific laws and requirements
• Manage regulatory submissions and approvals across India and ASEAN markets
• Monitor evolving regulatory environments and proactively advise stakeholders on key changes and implications
• Train and guide internal teams on regional regulatory requirements and best practices
• Build and sustain relationships with local regulatory bodies, industry associations, and external partners
• Review and approve product labeling, advertising, and promotional materials prior to market release to ensure regulatory compliance
• Support QA Leader to prepare for market entry in India and ASEAN countries
• Maintain and enhance Quality Management Systems and QA programs to align with global and regional standards
• Support and lead internal audits and regulatory inspections
• Oversee incident reporting processes related to medical devices, ensuring patient safety through transparency and informed decision-making

Required Qualifications

• Bachelor's degree in life sciences, engineering, or a related discipline (advanced degree preferred)
• Minimum 8 years of experience in Regulatory Affairs or combined Regulatory and Quality roles, with direct market approval experience in India and/or ASEAN countries
• Deep understanding of regulatory frameworks, including CDSCO (India), AMDD (ASEAN), and international standards such as ISO 13485
• Proven success in managing regulatory submissions and securing approvals
• Hands-on experience with quality management systems (e.g., ISO 9001, ISO 13485)
• Professional fluency in English
• Strong analytical skills with the ability to interpret complex regulations and implement them effectively
• Strong time-management and multitasking skills, with the agility to handle changing priorities, detail-oriented, organized, and adaptable to evolving business needs
• Excellent interpersonal and communication abilities, both internally and with external stakeholders
• Travel approximately 20%

Desired Qualifications

• Prior experience with endovascular interventional device technologies
• Exposure to post-market surveillance

What We Offer

Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.

We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for "profit-sharing". Learn more at gore.com/careers/benefits

Gore is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a protected veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.

Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact

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