This role has QA/RA responsibilities at the Singapore site to include product submissions for New Product Development and Sustaining activities for one of the GBUs as assigned by the reporting manager. The role will require the oversight and management of legacy / NPI product registration projects, in Rest of Asia and Emerging Market, such as license renewals, periodic updates and registrations to regulatory agencies, quality system compliance and audits, post market support (regulatory reporting), and continuous process improvement project involvement.
- B.S. Degree in Science and Engineering field with at least 3 – 5 years relevant experience within the regulatory affairs discipline
- Working knowledge of US and international medical device regulatory requirements
- Experience with QSR, Medical Device Directive, and ISO Quality System Standards
- Experience New / Existing Product Development that includes product registrations with the regulatory agencies
- Experience with Class II devices is mandatory
- Regulatory Affairs Certification desired, international experience is a plus
Interested candidates who wish to apply for the advertised position, please apply to send us an updated copy of your resume (Attn: YTN) or contact our office at +65 6318 9628 for a confidential discussion. We regret that only shortlisted candidates will be notified.
Job Code: YTN
Capita Pte Ltd
EA License No: 08C2893 | Reg No: R1547510 (Yantono)