POSITION IS 1 YEAR FROM START DATE WITH POSSIBLE EXTENSIONS.

On-Site

Top experience manager is looking for:

• Risk management,
• Product management,
• Product registrations,
• Impact assessment knowledge

Chinese or Japanese bilingual- optional.

Occasional Night call- 4-5 PM, 5-6 PM or 6-7 PM

Team environment- 5 people currently. Very open and collaborative team.

Experience Background :

• Medical Device, Pharmaceutical, Regulatory Affairs, Quality Assurance, SW Engineering, APAC regulatory submission, or APAC-related work under Quality Assurance/Engineering.

Job Description

• Keep the training records up to date to do the tasks.
• Report the status to a manager weekly.
• Plan and execute the given tasks proactively in a timely manner.
• Communicate weekly with affiliate RAs in different time zones to catch up on ongoing projects and discuss the issues to solve.
• Understand country-specific requirements and deliver those to internal stakeholders, including product management, engineering, labeling, etc., for product registration and change planning.
• Responsible for regulatory activities, including product registrations, impact assessment, etc.

List any preferred requirements that would stand out on a resume:

• Years of experience required: 5 Required
• Understand technical sections (risk management, product change control, biological evaluation)
• Education level/certifications: BS, MS

Daily tasks/duties and department interactions:

• prep submissions, regulatory strategy, review change control, other assigned tasks.
• Interacting with QA, Labeling, Engineer, PMO. Etc.

Description of work environment/department:

• Assigned Desk, quiet area but dynamic work
• Occasional night calls (after 5PM) with Affiliates.

Preferred interview method (one step or two step/phone or video conference): video interviews- two step interviews

Other

• Knowledge of International Standards, such as ISO13485, IEC60601.
• Knowledge of APAC country regulations, such as TGA, NMPA, PMDA, MFDS, HSA, TFDA, FDA, MOH, etc.
• Knowledge of Agile, SharePoint, MS Office, and other software to increase work efficiency.
• Ability to manage time and projects.
• Strict to work 40hrs per week.

Job Type: Contract

Pay: $50.00 - $54.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Experience level:

• 3 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• Risk management: 3 years (Preferred)
• product registration: 3 years (Preferred)
• Impact assessment knowledge: 3 years (Preferred)
• regulatory affairs: 3 years (Preferred)
• regulatory submissions: 3 years (Preferred)
• product change control: 3 years (Preferred)

Ability to Commute:

• Alameda, CA 94501 (Preferred)

Work Location: In person