Regulatory Affairs Lead

5 days ago

Singapore beBeeRegulatory Full time $90,000 - $120,000
Regulatory Affairs Specialist

The Regulatory Affairs Specialist plays a crucial role in ensuring compliance with regulatory requirements for medical devices. This involves staying up-to-date with relevant laws and regulations, particularly those related to the FDA.

Key Responsibilities:
  1. Support product registration activities, including preparation of registration dossiers, performance evaluation study design, and coordination with Clinical Research Organizations (CROs).
  2. Serve as the subject matter expert on medical device regulatory requirements, with a focus on FDA regulations.
  3. Interface with global regulatory authorities such as the FDA, Health Sciences Authority (HSA), and Medical Device Authority (MDA) to track submission progress and manage responses to queries or objections during the review process.
  4. Participate in clinical verification, product testing, data collection, and ongoing tracking activities to support both regulatory submissions and product performance validation.
  5. Prepare and submit scientific and technical documentation for special projects or novel product classifications.
  6. Foster professional relationships with regulatory bodies, third-party experts, and key opinion leaders to strengthen regulatory pathways and advocacy.
  7. Collaborate cross-functionally with internal teams (e.g., R&D, Clinical, Quality Assurance) to align regulatory strategy with overall business goals.
Requirements:
  1. A Bachelor's degree in Life Sciences, Pharmacy, Biomedical Engineering, or a related discipline.
  2. 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.
  3. Demonstrated skills in project management, planning, execution, and timely communication. Strong presentation and technical writing abilities are essential.
  4. Enthusiastic, proactive, and professional work ethic with a high level of accountability. Strong interpersonal skills and the ability to collaborate across teams.
  5. Detail-oriented with a high degree of responsibility. Able to handle regulatory pressure and manage tight timelines effectively.

This role requires a unique blend of technical knowledge, regulatory expertise, and interpersonal skills. If you have a passion for regulatory affairs and a drive to excel in this field, we encourage you to apply.

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