Quezon City - Regulatory Affairs Specialist(Medical Devices)Fresh grad is welcome to apply
About the role
We are seeking a highly skilled Regulatory Affairs Specialist (Medical Devices) to join our dynamic team at Business Trends Philippines' in Bonifacio Global City, Taguig City, Metro Manila. As a full-time role, you will play a crucial part in ensuring our medical device products comply with all relevant regulatory requirements and guidelines.
What you'll be doing- Staying up-to-date with the latest regulations and guidelines governing the medical device industry
- Preparing and submitting regulatory submissions, including product registration, clinical trial applications, and post-market surveillance reports
- Liaising with regulatory authorities and internal stakeholders to ensure timely and compliant product approvals
- Conducting risk assessments and developing risk management strategies for new and existing medical devices
- Providing regulatory support and guidance to the product development and quality assurance teams
- Maintaining comprehensive regulatory documentation and records
- Representing the company in regulatory affairs-related meetings and conferences
- Bachelor's degree in a relevant field, such as pharmaceutical sciences, biomedical engineering, or regulatory affairs
- Experience in regulatory affairs within the medical device industry as Intern or OJT
- Fresh graduate is welcome to apply
- Excellent knowledge of local and international medical device regulations, including the Philippines FDA, CE marking, and ISO 13485
- Strong problem-solving, communication, and project management skills
- Ability to work independently and as part of a cross-functional team
- Proficiency in MS Office suite and regulatory affairs software
- Willingness to learn and adapt to changing regulatory requirements
- Competitive salary and benefits package
- Opportunities for career development and professional growth
- Supportive and collaborative work environment
- Comprehensive training and development programs
- Health and wellness initiatives to promote work-life balance
About us
Business Trends Philippines' is a leading provider of innovative medical devices and pharmaceutical solutions in the Philippines. With a strong focus on quality, safety, and customer satisfaction, we are committed to improving healthcare outcomes and enhancing the lives of the people we serve.
Apply now for this exciting opportunity to join our team and contribute to the growth and success of our company.