Senior RA QA Executive

POSITION : Senior RA & QA Executive (Regional)

REPORTING : Associate Director, RAQA

POSITION SUMMARY
The Regulatory Affairs & QA Senior will play a key role in managing regulatory processes and quality assurance for medical devices brought to market through strategic partnerships with other companies. This role will focus heavily on regulatory affairs, managing product registrations, ensuring compliance with local regulations, and providing support for market expansion across Southeast Asia and the Middle East. The position offers high growth potential, with hands-on experience in multiple markets and product filings.

KEY RESPONSIBILITIES, ACROSS MARKETS AND BUSINESS UNITS

Regulatory Strategy and Analysis

1. Lead and manage regulatory submissions for medical devices in Southeast Asia, the Middle East, and other international markets.
2. Develop regulatory strategies for product registrations, ensuring compliance with local regulations (e.g., HSA, FDA, EMA, GCC, etc.).
3. Advise internal teams and external stakeholders on regulatory requirements and market access strategies for new regions and products.
4. Prepare and maintain accurate regulatory documentation for submissions, ensuring adherence to local and international standards.

Quality Assurance and Compliance

1. Oversee the implementation and maintenance of the quality management system (QMS) in line with global regulatory requirements.
2. Conduct audits and inspections to ensure compliance with regulatory and quality standards for both local and international markets.
3. Manage post-market surveillance processes, including corrective actions and compliance monitoring.
4. Develop and update internal procedures to ensure adherence to evolving regulatory requirements.

Cross-functional Coordination

1. Collaborate closely with external partners, including regulatory bodies and distributors, to ensure compliance with regulatory requirements for all products.
2. Provide regulatory expertise to cross-functional teams, ensuring all products meet regulatory standards and can be successfully launched.
3. Support strategic product launches by ensuring all necessary regulatory approvals are in place for market access.

Market and Product Expansion Support

1. Support new market entries by managing the regulatory process for medical devices and ensuring compliance with relevant laws and standards.
2. Stay updated on regulatory trends and changes across key markets, ensuring the company's compliance with new or revised regulations.
3. Play a critical role in facilitating market access in new regions, advising on regulatory pathways for market expansion.

Client and Stakeholder Engagement

1. Act as the regulatory liaison between the company and external partners, including medical device companies and regulatory authorities.
2. Maintain strong relationships with key regulatory bodies, distributors, and industry stakeholders to ensure smooth product launches and compliance.

ESSENTIAL SKILLS / EXPERIENCE

1. Bachelor's degree in Life Sciences, Engineering, or a related field.
2. At least 4 years of experience in regulatory affairs and quality assurance within the medical device industry.
3. In-depth knowledge of regulatory processes for medical devices, including product filings, approvals, and compliance requirements across Southeast Asia.
4. Strong experience in managing regulatory submissions to agencies such as HSA, FDA, EMA, GCC, and other relevant authorities.
5. Proven expertise in ISO standards, quality management systems (QMS), and regulatory compliance.
6. Experience with post-market surveillance and corrective action management.
7. Strong ability to work independently with minimal guidance in a fast-paced, dynamic environment.
8. Excellent communication, coordination, and problem-solving skills.
9. Fluency in English and additional languages (e.g., Chinese, Malay, Arabic) is a plus.
10. Willingness to work in a fast-growing, multi-regional business and to adapt to new regulatory challenges.

WHY THIS ROLE MATTERS

This role offers the chance to:

1. Drive Market Access: Play a pivotal role in ensuring that medical devices from strategic partners meet regulatory standards and gain access to important regional markets.
2. Develop Expertise in Regulatory Affairs: Gain hands-on experience in regulatory affairs across multiple regions, with a focus on navigating complex regulatory landscapes and ensuring compliance.
3. Shape the Future of Healthcare: Contribute directly to the success of medical devices that improve patient outcomes and expand access to healthcare across Southeast Asia and the Middle East.

ABOUT YOU
You are a regulatory affairs professional with a strong focus on ensuring compliance and market access. You thrive in fast-paced environments and are passionate about working with external partners to bring high-quality medical devices to new markets. With your strong regulatory expertise, you will drive growth and ensure the company's success in expanding product offerings in new regions. You are proactive, detail-oriented, and enjoy taking ownership of complex regulatory challenges.