head of regulatory affairs 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
91M0129083_1551259747
contact
jonathan ong, randstad
apply now

job description

about the company
A global market-leading medical device organization in Singapore with impressive year-on-year growth has created a highly commercial and strategic regulatory affairs function to lead projects/new initiatives within it’s business across ASEAN geographic locations. 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



  • Lead and manage the Medical Affairs and Regulatory Affairs teams in regulatory affairs, medical device safety reporting, medical communications, market access/pricing and compliance matters

  • Liaise with both internal and external regulatory stakeholders as per project requirements, participate in stakeholders engagement, helping network in Governmental agencies, Industry and Trade Association, Research Institutes

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

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

  • Accountable for product safety and compliance issues

  • 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 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 global board members and senior management team, you will potentially work in a matrix 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 8 years’ of regulatory affairs management 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 (FDA), ISO 9001, ISO 13485 would be a plus

  • Demonstrated ability to influence change upwardly and laterally across the business

  • 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

regulatory affairs,regulatory,product stewardship,product safety,fda,iso,hsa,rq,qa,capa,dossier

qualification

no additional qualifications required

educational requirements

Bachelor Degree