Senior Regulatory Affairs Specialist (Medical Device)

• Free meals (lunch), Subsidised breakfast, free beverages
• Excellent Staff benefits: AWS bonus, Performance bonus, yearly increment, Annual Leave, Medical & Insurance Benefit
• 5 days’ work week

Our client (MNC) is a global US manufacturer of medical devices. Due to fast expansion, they are actively looking for Senior Regulatory Affairs Specialist.

• Provide independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new or changed product launches.
• Write and file appropriate pre-market notification (510k) submission to US FDA; Write and maintain technical file / design dossier for CE marking a Class I, IIa and III medical devices;
• Prepare CSTD submission package to Singapore HAS. Maintain the dealer licenses and product licenses/clearance for importation and sales
• Support the international regulatory specialist within the global regulatory affairs department with product registration in accordance with their local regulatory requirements.
• Maintain current knowledge and stay abreast with the Federal USA polices/guidance, Canadian regulations, EU medical device regulation and Singapore HSA regulation pertaining to legal distribution of medical products. Implements and drives any new medical device requirement within the quality system environment.
• Communicate the Medical Device Reporting and Vigilance Reporting in accordance with the local authorities’ regulatory requirement. Collaborate with the corporate office to conduct any local field safety corrective actions or product recalls.
• Lead and collaborate with cross-functional teams to achieve regulatory compliance and departmental objectives.
• Manages, leads, and develops high performing teams.

• Degree/Diploma in Engineering or a related discipline
• Min 4-6 years of relevant experience in regulatory affairs within the medical devices industry
• Strong written and oral communication, and technical writing skills
• Strong critical thinking coupled with sound decision making skills

Interested candidates, please submit your updated resume in Word document (indicating your current salary and expected salary) through the Quick Apply button.

Tan Chuan Liang (Ryan)

Recruitment Manager

Right Recruit Pte. Ltd.

10 Anson Road, #33-03, International Plaza, Singapore 079903

EA Licence No: 23C1743 | EA Reg. no.: R23116422