Senior Quality Assurance

Talent Insider is an upcoming HR Consultancy Service, founded in 2021. Our clients have been some of the leading brands in Indonesia, and this service continues to expand.

Registered in Singapore & Indonesia, we can assist with your growth plans and strategies, and continue to expand our regional presence with strong regional partners to assist our client in recruitment and branding strategy.

• Participate And Coordinate In The Development Of Regulatory Strategies, In Conjunction With The Needs Of The Company, For Each Product Range And Change Establish Regular Review With Sales Marketing And Other Relevant Stakeholders To Ensure The Strategies Are In Alignment With Company Needs And Marketing Strategy. Identify Risks And/or Changes To The Strategies (if Any) And Involve The Relevant Stakeholders For Discussion On Action Plan
• Liaise With The Necessary Parties, BU RA, Registration Agency, Distributors, Sales Marketing And Other Relevant Stakeholders, To Understand And Evaluate The Requirements For Product Registrations For Designated Market
• Develop Timelines, Coordinate Receipt Of Technical Information From Appropriate Sources And Manage The Preparation Of Submissions For New Products, Amendment/variation Of Approved Products And Submissions That Support The Maintenance Of Existing Licenses Review The Technical Documents Obtained From Different Source Before Submission To External Party And/or Authority To Ensure The Documents Meet And/or Fulfill The Country Requirement/request Ensure The Documents Are Legalized And/or Notarized Where Required
• Develop Timelines, Coordinate Receipt Of Technical Information From Appropriate Sources And Manage The Preparation Of Responses To Regulatory Agency Questions And/or Requests For Information
• Review Product Development Documentation And/or Other Relevant Information To Assure Collection Of Appropriate Data For Regulatory Submissions And Regulatory Compliance. This Includes Use Of Appropriate Standards, Experimental Designs, Evaluation Criteria, And Statistical Rationale Per Regional Guidelines
• Participate In Business Interactions And Negotiations With Regulatory Agencies On Submission Requirements, Marketing Material, Labeling Claims, Etc
• Establish And Maintain The Quality System/GDP Procedures, Conduct Internal Audits And Management Review, Lead The On Site Audits To Ensure Compliance To GDP Requirements
• Ensure On Time Reporting Of Adverse Events To Authority Reviews Complaints And FSCA For Determination Of Adverse Events Reportability And That Reports Of Adverse Events Are Submitted To Appropriate Agencies In Accordance With Established Procedure And Domestic And International Regulations And Standards
• Establish And Maintain Specification And Procedure Related To Local Labelling And Change Control. Manage And Coordinate The Local Language Translation Activities For Label And/or Instructions For Use
• Participate In Any Other Tasks And/or Projects That Are Being Assigned By The Immediate Supervisor, As And When Required

• A minimum of a Diploma/Bachelor's degree
• A minimum of 3 years regulatory experience in medical device industry for Indonesia
• Details orientated, with emphasis on accuracy and completeness
• Effective written and oral communication skills
• Good organizational and planning skills drives for results
• Effective analytical/problem solving skills
• Read, analyze, and interpret and review scientific, technical and regulatory documents
• Effective communication information to peers, stakeholders and management
• Translate regulations and guidelines into terms that other functions can understand and apply
• Strong negotiation and influencing skills
• Good interpersonal skills that include working well in a team environment and the ability to lead others
• Team player with ability to collaborate with all stakeholders
• Ability to exercise reasonably independent judgment and discretion within a defined range of policies and practices
• Ability to handle multiple tasks and to prioritize/ schedule work to meet business needs with routine supervision
• Ability to identify areas of concern in moderately complex projects and manage change