Regulatory Affairs Specialist
Singapore, Singapore
Job Description
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- Participate in and contribute to regulatory strategy development and planning, including identifying regulatory risks and opportunities, and developing mitigation strategies.
- Maintains approvals/licenses/authorizations for existing marketing authorizations.
- Track regulatory milestones in the internal Regulatory database and report submission status to the management at the defined interval.
- Establish and conduct post-market surveillance.
- Keeps abreast of regulatory procedures and changes, conducts impact assessments, and provides periodic updates to relevant departments in the organization.
- Review and assess product/ process change impacts and craft regulatory notification plans.
- Prepare and submit regulatory filings, such as 510(k) submissions, premarket approval applications, and annual reports, in accordance with regulatory requirements and timelines.
- Responds to customers\xe2\x80\x99 and/or authorities\xe2\x80\x99 requests/inquiries and resolves issues regarding regulations and compliance matters.
- Assists in the review of product labeling/advertising materials for accuracy and regulations compliance.
- Assists in the preparation of dossiers for use in international registration by the Business development team.
- Provide regulatory guidance and support to cross-functional teams, including R&D, quality, clinical, and manufacturing, on regulatory requirements and implications for product development.
- Prepare and maintain regulatory documentation, such as regulatory strategies, technical files, and design dossiers, and ensure accuracy and completeness of documentation.
- Ensure the registration database is updated and inform the relevant departments of any changes.
- Work with Quality Assurance Team on complaints, NCRs, CAPAs, medical device reporting, and field actions.
- Participate in the regulatory inspection by the regulatory authorities and certification bodies.
- Bachelor\xe2\x80\x99s or master\xe2\x80\x99s degree or higher in Life Science/ Molecular Biology/ Biotechnology/ Biomedical Engineering, or equivalent combination of education and experience.
- Strong written and oral communication, and technical writing skills in both English and Chinese
- At least 3 years or more of direct experience in regulatory affairs function in a regulated environment (medical devices/pharmaceutical industry).
- Technical knowledge and experience to work effectively with others in diverse areas of business (Operations, R&D, Business Development, Human Resources, Procurement, Finance), is preferred.
- Strong in communication, presentation, documentation, and interpersonal skills, and a team player.
- Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
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Job Detail
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Job IdJD1307795
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationSingapore, Singapore
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EducationNot mentioned