- Salary: Undisclosed
- Work Type: Permanent / Full Time
- Min. Education Level: Degree
- Field of Study: Science
- Years of Experience: 3
- Skills: Health Sciences Authority (HSA), Time management, Multi-tasking
- Regional Role covering SEA
- Well recognized Diagnostics MNC
About Our Client
Highly successful multi-national diagnostic company specialising in healthcare and life sciences
The Specialist in Regulatory Affairs is a dynamic individual with combined knowledge of scientific, regulatory and business issues. The challenges include planning and execution of regulatory activities necessary for timely product registration while complying with regulatory requirements and maintaining good contact with regulatory authorities, locally as well as within South East Asia (SEA). The key responsibilities of the position are to:
- Generate, review, follow-up and maintain global product registration applications, submissions and files update.
- Work closely on Regulatory matters from global regulatory members, local authority as well as across other disciplinary Regulatory Agencies in SEA.
- Supports regulatory inquiries from Sales & Marketing, R&D and other functional key members.
- Keeps track of registration and establishment of licenses (renewals, variations, etc).
- Generate, review and maintain SOP's relevant for registration of IVD products.
- Review of promotion materials
- Responsible for ensuring on-going compliance to applicable quality and EHS regulations and standards (e.g., ISO, US FDA, MDD, IVD Directive, EU, OSHA, etc.).
The Successful Applicant
- A Diploma or Degree in a Science-related discipline
- At least 3 years of working experience in a similar role or medical device industry
- Familiarity with the Health Sciences Authority (HSA) of Singapore medical device regulations and other regulatory requirements in SEA.
- Thrive in a fast paced work environment, while possessing the ability to quickly change priorities
- Able to perform multiple tasks simultaneously
- Demonstrated strong attention to detail
- Ability to work under pressure to meet deadlines
- Minimal travel required
What's On Offer
Apply for this Job
Apply online using the form below or phone Sophia Davison on + 65 6533 2777 quoting jobref H1858600