Job Description
This role has regulatory affairs responsibilities include define regulatory compliance strategy, product submissions for New Product Development and Sustaining activities as assigned by the reporting manager. The role will require the oversight and management of legacy / New Product Introduction product registration projects such as license renewals, periodic updates and registrations to regulatory agencies, quality system compliance and audits, post market support (regulatory reporting), and continuous process improvement project involvement.You will work closely with cross-functional teams to prepare and submit regulatory documents, provide guidance on regulatory strategies, and monitor changes in regulations that impact our products.
Responsibilities + Skills
Consolidated findings or any non-compliance / test concerns to be discussed with Senior Engineer before communicating to the Project Design Team for immediate attention.Working with Certification bodies such as Intertek, CQC-China, JQA-JP, and SIRIM/ST-Malaysia for product certification.
Education
Determines protective software approvals requirements, test scope, develops a preliminary plan of compliance, and determines project specifications such as cost, lead time, and sample requirements by analysing product information with Electronic software team.
Experience
