senior regulatory affairs specialist 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
91M0131787_1554804672
contact
jonathan ong, randstad
apply now

job description

about the company


A market-leading medical device organization in Singapore with impressive year-on-year growth has engaged us to be their sole recruitment provider to seek for a highly commercial and strategic regulatory affairs function to oversee projects/new initiatives within it’s business


This cutting-edge multinational is always at the forefront when it comes to innovation and medical solutions hence one should inevitably grow and develop within the business.


about the job



  • Take ownership of business units with regards to regulatory affairs, medical device safety reporting, medical communications, market access/pricing and compliance matters

  • Ensure that regulatory & medical affairs teams interface with key functional groups

  • Accountable for product safety and compliance issues in relation to medical equipment, devices and capital expenditure

  • Liaise with both internal and external regulatory stakeholders as per project requirements, participate in stakeholders engagement

  • Provide expertise to both lifecycle maintenance projects and to exciting new product registration across the region

  • Develop and implement procedures and processes to ensure organisational health and operational excellence

  • Manage adherence to compliance, policies, procedures and relevant legislation

  • Work closely with the existing RA Team to monitor regulatory status of all products being marketed and business operations being conducted in the region, via distributors for products from all business units, ensuring compliance is observed.

  • Active representation in industry issues likewise be involved in marketing initiatives

  • Proactive liaison with agencies, health professionals & media, to facilitate voice of customer objectives


about the manager/team


Reporting in to the business leader in Regulatory Affairs, you will potentially work in a cross-functional team of professional priding strong team focus and open communications. In addition, you will be part of an organization that prides company values and culture


skills and experience required



  • Degree in science, health-related discipline or equivalent

  • At least 3 years’ of regulatory affairs experience.

  • Working exposure in a medical device, biotechnology, scientific or pharmaceutical company would be advantageous

  • Familiar with fundamental principles of clinical, regulatory, registration, quality systems, audits, reimbursement and compliance issues within the region

  • Hands on knowledge of submissions to regulatory boards i.e. HSA, notified bodies

  • Proven people management experience and comfortable working in a matrix cross-functional corporate environment

  • Have a proven track record of delivery various successful applications across the region



To apply online please use the 'apply' function, alternatively you may contact us at 65171622 for a confidential discussion. Do 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