job description
Join Zoll Medical Corporation as a Senior Regulatory Affairs Specialist for the APAC region, where you will play a pivotal role in ensuring regulatory compliance and driving strategic initiatives across Asia-Pacific markets. This is a unique opportunity to work with a global leader in medical technology, contributing to life-saving innovations while navigating complex regulatory landscapes.
Based in the vibrant and dynamic locations of Bali, Indonesia, you will collaborate with cross-functional teams to develop and implement regulatory strategies, ensuring timely product approvals and market access. Your expertise will be instrumental in maintaining compliance with regional and international regulations, fostering strong relationships with regulatory authorities, and supporting business growth in the APAC region.
If you are a detail-oriented professional with a passion for regulatory affairs and a desire to make a meaningful impact in the healthcare industry, we invite you to apply and become part of our mission to advance medical technology and improve patient outcomes.
Responsibility
- Develop and execute regulatory strategies for product registrations, renewals, and lifecycle management across APAC markets.
- Serve as the primary liaison with regulatory authorities, ensuring compliance with local and international regulations.
- Prepare and submit regulatory documentation, including dossiers, technical files, and responses to agency queries.
- Monitor and interpret regulatory changes, providing guidance to internal teams to ensure ongoing compliance.
- Collaborate with R&D, Quality, and Marketing teams to align product development and commercialization with regulatory requirements.
- Conduct regulatory risk assessments and provide strategic recommendations to senior management.
- Support audits, inspections, and regulatory submissions, ensuring adherence to company policies and industry standards.
- Mentor junior team members and contribute to the continuous improvement of regulatory processes.
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, Engineering, or a related field. Advanced degree preferred.
- Minimum of 5 years of experience in regulatory affairs within the medical device or healthcare industry, with a focus on APAC markets.
- In-depth knowledge of regulatory requirements in key APAC markets (e.g., Indonesia, Malaysia, Singapore, Thailand, Australia).
- Proven track record of successful product registrations and interactions with regulatory agencies.
- Strong analytical, problem-solving, and project management skills.
- Excellent communication and interpersonal skills, with the ability to influence stakeholders at all levels.
- Fluency in English; proficiency in additional APAC languages is a plus.
- Certification in regulatory affairs (e.g., RAC) is highly desirable.