Regulatory Affairs Executive at CorDx

Singapore, , Singapore -

Full Time

Start Date

Immediate

Expiry Date

31 May, 26

Salary

0.0

Posted On

02 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Product Registration, Dossier Preparation, Performance Evaluation Study, CRO Management, Regulatory Affairs, Medical Device Laws, Regulatory Agencies Interface, Product Testing, Clinical Verification, Data Collection, Key Opinion Leaders, Cross-functional Collaboration, ISO13485, Medical Device Quality Management, IVD Products, Project Management

Industry

Biotechnology Research

Description

Job Responsibilities Product registration: including preparation of registration dossier, design of performance evaluation study and manage execution and communication with CRO (clinical research organization). Be the subject matter expert on medical devices laws and regulations for product registration in company’s regions of interest. Interface the communication with regulatory agencies, e.g. Health Science Authority, Medical Device Authority, Food and Drug Administration, track the progress of product registration, and resolve problems raised by reviewers during the review process. Involve in the process of product testing, clinical verification, data collection and relevant tracking. Submit to agencies scientific special projects on behalf of the company. Establish collaborative and cooperative working relationship with key opinion leaders and the regulatory bodies. Collaborate with cross-functional teams to meet projects goals with overall organizational objectives. Any other ad-hoc duties or projects as required by the management team. A bachelor's degree in in Life Sciences, Pharmacy, or a related field Familiar with ISO13485 quality management system, solid medical device quality management qualifications, including but not limited to Class B, C and D medical devices. Expert in medical device product registration laws and regulations, able to independently draft registration dossier. You shall have complete registration experience of Class B, C and D medical devices. Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR, Immunoassay etc. Familiar with IVD product development and commercialization life cycle. Systematically project management, good planning, execution and timely communication. Good presentation skills. Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player. Meticulous and strong sense of responsibility; able to handle stress and tight schedule.

Responsibilities

Responsibilities include managing product registration processes, such as dossier preparation, study design, and communication with regulatory agencies like the FDA and Health Science Authority. The role requires serving as the subject matter expert on medical device laws and regulations for product registration in target regions.