Location
Alameda, CA | United States
Job description
For further information please contact our Talent Specialist:
Divya | (224) 369-2969
Rashi | 630 847 1027
Title: RA Specialist II
Location: Alameda, CA
Duration: 12 Months ( with possible extensions)
100% Onsite
Description:
Preferred/Optional: Bilingual (Japanese or Chinese)
Experience Background (Any): Medical Device, Pharmaceutical, Regulatory Affairs, Quality Assurance,
SW Engineering, APAC regulatory submission, or APAC-related work under Quality Assurance/Engineering.
Note:
- Responsible for product packaging, and labeling.
- Communicating with stakeholder
- Risk Management, Product management, product registration, and CHANGE CONTROL are required.
- GLOBAL EXPERIENCE IS HIGHLY Preferable
- Communicate weekly with different RAs.
- 5 PLUS YEARS of Experience in the same field with a master 3 plus years.
- Medical Device and Pharmaceutical experience are nice to have.
- Should be Abel to accommodate overtime working with different time zones or any after-hours Calls. (Occasional Night call- 4-5 PM, 5-6 PM or 6-7 PM)
- Previous APAC experience preferred.
- Experience in assessments, submission, and US submission.
Interviews
Mainly 1 round with HM But depending upon interview feedback can be 2 rounds as well.
Job Description
- Responsible for regulatory activities, including product registrations, impact assessment, etc.
- Understand country-specific requirements and deliver those to internal stakeholders, including product management, engineering, labeling, etc., for product registration and change planning.
- Communicate weekly with affiliate RAs in different time zones to catch up on ongoing projects and discuss the issues to solve.
- Plan and execute the given tasks proactively in a timely manner.
- Report the status to a manager weekly.
- Keep the training records up to date to do the tasks.
- Knowledge of International Standards, such as ISO13485, and 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.
- Strictly to work 40 hours per week.
Duties:
- Responsible for implementing and maintaining the effectiveness of the quality system. Supports manufacturing/operations day-to-day activities for change control.
- Provides consultation/advice to regulatory specialists for change control and product development.
- Provides regulatory direction/interpretation on team activities.
- Interprets and applies regulatory understanding to support of products and teams.
- Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide.
- Handles regulatory activities involved in documentation, labeling,field support.
- Applies regulatory and technical knowledge to a wide variety of complex work assignments.
- Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.
- Ensures compliance to and is able to demonstrate knowledge of site and division-level policies and procedures. understand technical sections (risk management, product change control, biological evaluation)
Exempt/Non Exempt: Non Exempt
Experience: 2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs function, 5+ Required education level/certifications: BS, MS
Skills: Knowledge of regulations and standards affecting IVDs and/or biologics
Education: BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc. (MS degree- will consider 3+ yrs of experience, BS degree- must have 5+ yrs of experience)
Daily tasks/duties and department interactions: prep submissions, regulatory strategy, review change control, and other assigned tasks. Interacting with QA, Labeling, Engineer, and PMO. Etc.
Description of work environment/department: Assigned Desk, quiet area but dynamic work, Occasional night calls (after 5 PM) with Affiliates
T op experience manager is looking for Risk management, product management, product registrations, impact assessment knowledge
Occasional Night call- 4-5 PM, 5-6 PM or 6-7 PM
Team environment- 5 people currently. Very open and collaborative team.
About us:
DivIHN , the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.
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