Regulatory Affairs - Manager

Responsibilities

• Identify Regulatory requirements in Stay up-to date with Regulatory landscape in each Marketing Territory
  
• Company representative, committee member in local medical device industry association, MMDA
  
• Consistently initiate, validate, review, plan & strategies to ensure products compliance with applicable statutory and regulatory requirements.
  
• Communicate Regulatory updates to relevant internal stakeholders ensuring alignment across departments
  
• Plan and initiate Process Improvement, digitalization of RA workflows
  
• Be responsible for Medical Device Establishment/Dealer License with authority.
  
• Oversee Pre-Market Medical Device Registration, Change Notification, Special Authorisation/ Exemptions with relevant government bodies.
  
• Oversee device related incidents/ complaints for medical device reporting requirements. Ensure reporting are timely. Fulfill necessary requirements as part of post-market surveillance.
  
• Oversee compliance to advertisement regulation and respective labeling requirements in each marketing territory
  
• Oversee and Supervise Other Authorities Compliances with relevant authorities / government bodies such as Poisons (MOH MY, HSA SG), Flammables & Hazardous Substance (HS) (NEA SG); SIRIM/ IMDA (MY; SG); DVS/ AVS (MY; SG)
  
• Plan and Lead Implementation of yearly RA Audits internally
  
• Support external regulatory agency audits/ Principal audits/ Supplier audits, providing regulatory input to minimize potential for findings of non-compliance.
  
• Support internal audits of respective subsidiaries and associated companies in South-East Asia on Regulatory matters
  
• Work closely with Conformity Assessment Body relevant to Product Risk Assessment and relevant regulatory implementation changes
  
• Support of any regulatory issues relevant to Custom Import
  
• Oversee & Assist Pharmacists/ Qualified Personnel with Poison A License & MOH inspection related matters

Requirements

Qualifications

• Minimum Degree in science or related discipline with at least 7 years of similar experience.
  
• Microsoft Office (Outlook, Excel, Word, PowerPoint, etc.) Organized
  
• Good Leadership, People managing skills; Able to coach and train
  
• Possess good communication skills and ability to liaise with authorities, consultants, auditors and foreign manufacturers.
  
• Possess knowledge and experience in handling Medical Device Registrations/ Compliance in Malaysia, Singapore and Indonesia.
  
• Possess working knowledge of ISO 13485, ISO 9001 & GDPMD
  
• Basic bio-medical knowledge and ability to understand products (medical devices)
  
• Understand daily operation flow and ability to identify inefficiencies to make improvement.
  
• Meticulous, Able to work independently.
  
• Good analytical and presentation skills.
  
• Proactive, high performance, result oriented and manage projects with ethical integrity