Total 2 Senior Executive affairs manager job vacancies in SOH01 - Singapore HP Campus Block 1 (SOH01)

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.

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.

Due to our rapid expansion to serve more children, we invite people to join us in transforming the lives entrusted to us.

You will be responsible for providing support to the following areas, including (but not limited to):

Front Desk & Reception

• Reception and front desk duties (eg: handling walk-in queries, phone calls, voice mails, in-coming and out-going mails)
• Managing room booking system
• Managing and maintaining sick bay for students and ensuring first-aid kit items are constantly refreshed for emergencies

General Administration

• Printing and disseminating communication letters to students
• Managing and updating of student data and files
• Processing of all student-related matters like SMART card applications, Disability Data Registry applications and bus transport subsidies
• Ensuring all moneys (e.g. School fees) collected are accounted for with the Finance Department
• Frequent updating and maintenance of notice boards

Others

• Ensuring a well-maintained key issuance system & Security passes for visitors
• Ensuring adequate stock of stationery & spare uniforms and to place orders when required
• Supporting other school events/activities

• Minimum O Level / ITE / NITEC certificate
• 1 to 3 years of relevant work experience in related administrative fields
• Good customer service skills
• Strong organisational skills with strong detail orientation
• Strong verbal and written communication skills in English
• Ability to work in a fast paced, dynamic and challenging work environment
• Desire to learn about Autism and the passion to help special needs students.
• Proficiency in Microsoft Office applications

We offer a competitive salary and benefits package and the professional advantages of a dynamic environment that supports your development and recognises your achievements.

We apologise that only shortlisted candidates will be notified.

Our organisation is committed to protecting children and young people from harm. We require all applicants to undergo an extensive screening process prior to hire.