Regulatory Affairs - Assistant Manager

• Identify Regulatory requirements in Stay up-to date with the Regulatory landscape in each Marketing Territory.
  
• 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 is 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 the 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

• Minimum Degree in Biomedical Science or related discipline with at least 5 years of similar experience.
  
• Good Leadership, People managing skills. Able to coach and train.
  
• Proactive, high performance, result oriented and manage projects with ethical integrity.
  
• Excellent written and Verbal communication skills with the ability to listen, articulate and advocate.
  
• Possess good negotiation and relationship building skills with Authorities, Consultants, auditors and foreign manufacturers.
  
• Scientific knowledge must be able to digest complex data while keeping the big picture through good analytical skills.
  
• Technical system skills (e.g. MS office applications, databases, efficient online research).
  
• Excellent organizational skills, meticulous, planning and presentation skills.
  
• Manage multiple projects and deadlines.
  
• Ability to identify compliance risks and escalate when necessary.
  
• Demonstrate both creative and critical thinking skills.
  
• Good at understanding processes/workflows, keen to innovate and improve.
  
• Possess working knowledge of ISO 9001 & GDPMD, ISO13485.