Regulatory Affairs Executive

CorDx; Singapore; On-site; SGD 100,000 - 125,000; Full time

Job summary

A medical device company in Singapore is seeking a qualified individual to manage product registration processes for various medical devices. The role requires expertise in medical device regulations and a bachelor's degree in a related field. Responsibilities include collaborating with cross-functional teams and dealing directly with regulatory agencies. Candidates should have strong project management skills, attention to detail, and the ability to work under pressure.

Qualifications

• Familiar with ISO13485 quality management system.
• Experience with Class B, C and D medical devices registration.
• Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR.

Responsibilities

• Manage product registration and communicate with regulatory agencies.
• Collaborate with teams to meet project goals.
• Establish relationships with regulatory bodies.

Skills

Project management

Communication skills

Strong execution ability

Attention to detail

Proactive work attitude

Education

Bachelor's degree in Life Sciences, Pharmacy, or a related field

Job description

Job Responsibilities

1. Product registration: including preparation of registration dossier, design of performance evaluation study and manage execution and communication with CRO (clinical research organization).
2. Be the subject matter expert on medical devices laws and regulations for product registration in company’s regions of interest.
3. 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.
4. Involve in the process of product testing, clinical verification, data collection and relevant tracking.
5. Submit to agencies scientific special projects on behalf of the company.
6. Establish collaborative and cooperative working relationship with key opinion leaders and the regulatory bodies.
7. Collaborate with cross-functional teams to meet projects goals with overall organizational objectives.
8. Any other ad-hoc duties or projects as required by the management team.

Qualifications

1. A bachelor's degree in in Life Sciences, Pharmacy, or a related field
2. Familiar with ISO13485 quality management system, solid medical device quality management qualifications, including but not limited to Class B, C and D medical devices.
3. Expert in medical device product registration laws and regulations, able to independently draft registration dossier.
4. You shall have complete registration experience of Class B, C and D medical devices.
5. Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR, Immunoassay etc.
6. Familiar with IVD product development and commercialization life cycle.
7. Systematically project management, good planning, execution and timely communication. Good presentation skills.
8. Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player.
9. Meticulous and strong sense of responsibility; able to handle stress and tight schedule.