Regulatory Affairs Executive
Full-time
Senior Executive
1 day ago
Job Responsibilities
Product registration: including preparation of registration dossier, design of performance evaluation study and manage executi..
Job Responsibilities
- Product registration: including preparation of registration dossier, design of performance evaluation study and manage execution and communication with CRO (clinical research organization).
- Be the subject matter expert on medical devices laws and regulations for product registration in company’s regions of interest.
- Interface the communication with regulatory agencies, e.g. Health Science Authority, Medical Device Authority, Food and Drug Administration, track the progress of product registration, and resolve problems raised by reviewers during the review process.
- Involve in the process of product testing, clinical verification, data collection and relevant tracking.
- Submit to agencies scientific special projects on behalf of the company.
- Establish collaborative and cooperative working relationship with key opinion leaders and the regulatory bodies.
- Collaborate with cross-functional teams to meet projects goals with overall organizational objectives.
- Any other ad-hoc duties or projects as required by the management team.
Job Qualifications:
- A bachelor's degree in Life Sciences, Pharmacy, Biotechnology or a related field
- Systematically project management, good planning, execution and timely communication. Good presentation skills.
- Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player.
- Meticulous and strong sense of responsibility; able to handle stress and tight schedule.
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