RA Specialist (TH)

Ready to navigate the intricate landscape of medical device regulations while ensuring the highest quality standards? If you're passionate about regulatory affairs and quality assurance, join our client and make a significant impact in the field of healthcare.

Our client is a young, thriving, and rapidly expanding force in the world of Medical Device Regulatory Affairs and Market Access, pioneering the way for innovative medical devices and in-vitro diagnostics (IVD) across Southeast Asia.

They are transforming the landscape of medical device access in Southeast Asia. Unlike traditional consulting firms, they house a dedicated team of in-house regulatory affairs specialists, offering unmatched expertise to both manufacturers and distributors. Our client has local presence means you have a long-term partner you can rely on, erasing the need for external consultants.

Our client acts as your in-country representative, handling device registrations, giving you independence and flexibility in your market strategies. Beyond document storage, our client provides continuous insights into the evolving regulatory landscape, ensuring compliance even in times of heightened surveillance. With their seamless importation and distribution services, accessing new markets is effortless. Join our client in redefining medical device access across Southeast Asia, making healthcare innovations accessible to millions.

Being a Regulatory Affairs Specialist has its perks!

• Impact: Your work ensures that medical devices meet regulatory standards and maintain top-notch quality.
• Learning: You'll stay at the forefront of industry regulations and quality management.
• Collaboration: You'll collaborate with a diverse team of experts across Southeast Asia.
• Influence: Your insights and expertise will guide decision-making in the company.
• Professional Growth: You'll have opportunities for professional growth and advancement in a fast-growing field.

Your Role as a Regulatory Affairs Specialist:

Regulatory Affairs Responsibilities:

• Investigation and Classification: Determine if a Health Product qualifies as a medical device, assess its risk classification, and identify the most suitable submission route.
• Documentation Maestro: Skillfully prepare and submit documents for Initial, Renewal, Variations/Change Notification of medical devices, and diligently follow through until approval is secured.
• Effective Communication: Maintain open lines of communication with manufacturers and ensure timely relay of any feedback from Authorities to facilitate successful product registration.
• Client Liaison: Professionally address regulatory concerns raised by customers, providing swift and efficient resolutions.
• Data Custodian: Meticulously manage the regulatory database, ensuring it remains accurate and up-to-date.
• Regulatory Intelligence: Conduct thorough research to compile Regulatory Intelligence Reports, staying abreast of relevant topics.
• Trend Tracking: Keep a watchful eye on emerging trends in industry regulations, evaluating their potential impact on internal projects and proactively providing regulatory updates to the Marketing Manager.
• Collaborative Support: Collaborate with the sales team in client discussions concerning regulatory matters when required.
• Policy Development: Create and maintain Standard Operating Procedures, local working practices, and regulatory affairs policies to uphold and enhance regulatory compliance.
• External Engagement: Establish productive relationships with external entities concerning Indonesia's medical device regulatory requirements.
• Compliance Oversight: Handle post-marketing activities with Authorities, including mandatory problem reporting, field safety correction actions, recalls, and more.
• Advocate for Compliance: Ensure that both the company and its supply chain understand and adhere to regulatory requirements and other relevant statutory obligations.

What Our Client Is Looking For:

• Educational Foundation: Hold at least a Bachelors Degree or higher in Biology, Chemistry, Pharmacy/Pharmacology, Biotechnology, or an equivalent field.
• Industry Experience: Possess a minimum of 3 years of experience in the medical device industry, particularly in regulatory affairs or related fields.
• Tech Savvy: Experience in transacting with NBTC for securing approval for Bluetooth connectivity devices is advantageous.
• Language Skills: Fluent in English with excellent writing and verbal communication abilities.

Who You Are:

You're not just a regulatory affairs and quality assurance specialist; you're a sentinel of compliance and a guardian of quality in the medical device industry. Your commitment to upholding the highest standards is unwavering. Your analytical mind can navigate the labyrinthine corridors of regulations, and your meticulous attention to detail ensures that quality reigns supreme. As a communicator extraordinaire, you excel at collaborating with a diverse array of internal and external stakeholders.

If you're ready to champion regulatory compliance and uphold the gold standard in quality for medical devices, we invite you to join the exceptional team.