Job Responsibilities:
- Support product registration activities, including the preparation of registration dossiers, performance evaluation study design, and coordination with CROs (Clinical Research Organizations).
- Act as the subject matter expert on medical device regulatory requirements, with a particular focus on FDA regulations. Stay current with relevant laws and ensure internal practices remain compliant.
- Interface with global regulatory authorities such as the FDA, Health Sciences Authority (HSA), and Medical Device Authority (MDA). Track submission progress and manage responses to queries or objections during the review process.
- Participate in clinical verification, product testing, data collection, and ongoing tracking activities to support both regulatory submissions and product performance validation.
- Prepare and submit scientific and technical documentation for special projects or novel product classifications.
- Foster professional relationships with regulatory bodies, third-party experts, and key opinion leaders to strengthen regulatory pathways and advocacy.
- Collaborate cross-functionally with internal teams (e.g., R&D, Clinical, Quality Assurance) to align regulatory strategy with overall business goals.
- Undertake any additional regulatory tasks or projects as assigned by the management team.
Job Requirements:
- A Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Engineering, or a related discipline.
- Minimum 2 years of hands-on experience working with the FDA on medical device registration, submissions (e.g., 510(k), IDE), or related regulatory pathways.
- Demonstrated skills in project management, planning, execution, and timely communication. Strong presentation and technical writing abilities are essential.
- Enthusiastic, proactive, and professional work ethic with a high level of accountability. Strong interpersonal skills and the ability to collaborate across teams.
- Detail-oriented with a high degree of responsibility. Able to handle regulatory pressure and manage tight timelines effectively.
- Willing and able to travel to the United States for one month every six months as part of regulatory project and stakeholder engagement needs.