regulatory affairs specialist - medical devices in Singapore

posted
contact
jonathan ong, randstad
job type
permanent
apply now

job details

posted
location
singapore
specialism
life science
job type
permanent
working hours
Full-Time
reference number
91M0132359_1554860062
contact
jonathan ong, randstad
apply now

job description

about the company

This global leading FMCG organization is no stranger to both is consumers and competitors. They have recorded impressive year-on-year growth in recent years and are continuing to expand their businesses across the region. In conjunction with record breaking revenues across all their brands and franchise - predominantly in the medical device product line, they are aware of the importance of quality standards in Singapore hence seeking for a stellar Regulatory Affairs talent to join their team

about the job
  • This individual will be responsible for operational and administrative roles from a regulatory perspective together with having his or her eyes on all risk classes for its surgery and orthopaedics product line
  • You will also be involved in the preparation of submissions to the local health authority for new products and variations to existing products in line with Marketing launch plans, with guidance from senior regulatory colleagues as necessary
  • Maintaining departmental and source company databases of regulatory approvals likewise regular interactions with stakeholders in the business
  • You will also maintain an awareness of new legislation, policies and guidelines impacting the assigned product portfolio, contribute to continuous review and improvement of processes and to ensure consistent, efficient and effective practices
  • In addition, this individual would ideally leverage on solid working knowledge and best practices of the global regulatory environment, including proposed laws, regulations and guidance in order to contribute to the development of business strategies
about the manager / team
  • You will be a member of the local regulatory affairs department that practices a transparent and productive working environment. Reporting in to the RA Manager, you will support end to end operational and administrative roles from a regulatory aspect
skills and experience required
  • Bachelor's degree or equivalent in Science and Engineering or related discipline
  • At least 2 years of work experience in a medical device regulatory environment
  • Open to a long term contract position with the possibility of conversion to permanent
  • Familiarity with the regulatory systems and product registration requirements in Singapore
  • Ability to interpret complex issues, then relay information in a clear, accurate and concise manner
  • Passionate for Regulatory Affairs, achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environments
  • Proactive team player, able to take charge, follow-through and understands the need to meet critical deadlines
  • Must be able to develop and maintain excellent working relationships and work successfully within a team environment


To apply online please use the 'apply' function, alternatively you may contact us at 65171622 for a constructive discussion. Note that only shortlisted candidates will be notified
(EA: 94C3609/ R1551260)






skills

no additional skills required

qualification

no additional qualifications required

educational requirements

Bachelor Degree