job description
Join People Profilers as an RA/QA Specialist and play a pivotal role in ensuring compliance and quality within the healthcare and medical sector. This contract position offers a unique opportunity to work in the vibrant regions of Bali, including Canggu, Ubud, Denpasar, Jimbaran, Nusa Dua, Kuta, and Badung. You will be responsible for managing technical files, product registrations, and ensuring adherence to regulatory standards.
As an RA/QA Specialist, you will collaborate with cross-functional teams to maintain high-quality standards and regulatory compliance. Your expertise will be crucial in navigating the complexities of product registration processes and ensuring that all documentation meets regulatory requirements. This role is ideal for professionals who are detail-oriented, analytical, and passionate about maintaining the highest standards of quality and compliance in the healthcare industry.
People Profilers is committed to fostering a dynamic and inclusive work environment. We offer competitive compensation, opportunities for professional growth, and the chance to make a meaningful impact in the healthcare sector. If you are looking for a challenging and rewarding role in a beautiful and inspiring location, we encourage you to apply.
Responsibility
- Manage and maintain technical files and documentation to ensure compliance with regulatory standards.
- Oversee the product registration process, ensuring all submissions are accurate and timely.
- Collaborate with cross-functional teams to ensure adherence to quality assurance protocols.
- Conduct regular audits and inspections to maintain high-quality standards.
- Stay updated with the latest regulatory requirements and industry best practices.
- Provide training and guidance to team members on regulatory and quality assurance matters.
- Investigate and resolve any quality or compliance issues that arise.
- Prepare and submit regulatory reports and documentation as required.
Qualifications
- Bachelor's degree in a relevant field such as Life Sciences, Pharmacy, or Engineering.
- Proven experience in regulatory affairs and quality assurance within the healthcare or medical industry.
- Strong knowledge of technical files and product registration processes.
- Excellent analytical and problem-solving skills.
- Ability to work independently and as part of a team.
- Strong communication and interpersonal skills.
- Attention to detail and a commitment to maintaining high standards of quality and compliance.
- Familiarity with regulatory agencies and their requirements.