ASSOCIATE MANAGER (Regulatory Affairs) ($5000-$7000/AWS/VB)

• Assist the department head in managing the department activities, and as a designee during his/her absences. Tasks include but not limited to team capacity planning, process improvement, etc.
• Formulate the annual budget and manages the regulatory budget as needed. This include the monthly forecast spending review against the budget.
• Provide independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new or changed product launches.
• Write and file appropriate pre-market notification submission to FDA; Write and maintain technical file / design dossier for CE marking a Class I, IIa and III medical devices; Write and maintain submission to Health for device licensing.
• Prepare CSTD submission package to Singapore Health Science Authority. Maintain the dealer licenses and product licenses/clearance for importation and sales
• Support the international regulatory specialist within the global regulatory affairs department with product registration in accordance with their local regulatory requirements.
• Maintain current knowledge and stay abreast with the polices/guidance, regulations, EU medical device regulation and Singapore HSA regulation pertaining to legal distribution of medical products. Implements and drives any new medical device requirement within the quality system environment.
• Review and approve scientific and promotional materials as well as documentation change requests to ensure regulatory compliance.

• Minimum Degree/Diploma in relevant fields or equivalent.
• Minimum 3 years of relevant experience.
• Experiences in regulatory affairs in medical devices is a plus.
• Excellent communication and interpersonal skills

• Salary Offer $5000-$7000

Career Edge Asia