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Regulatory Affairs Coordinator
Location:
US-CA-San Jose - 95131-1807
Jobcode:
JOB89260
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Position : Regulatory Affairs Coordinator
Location : San Jose, CA
Duration : 12 Months
Total Hours/week : 40.00
1st Shift
Client: Medical Device Company
Job Category: Regulatory Affairs / Compliance
Level of Experience: Entry Level
Employment Type: Contract on W2 (Need US Citizens or GC Holders Only)

Job Description:
• The Regulatory Affairs Coordinator is responsible for a variety of regulatory affairs administrative activities and projects with oversight from senior regulatory staff.
• This includes tasks and deliverables such as supporting international product submissions, registration life cycle maintenance including change control, and other related activities.

Job responsibilities:
• Acts as a liaison for the international RA team by tracking request for information and monitoring international laws/regulations.
• Provides data collected from surveys, etc. as requested by international personnel and other corporate groups.
• Manage and coordinate the electronic Global Product Submission (eGPS), Regulatory Information Management (RIM) database to ensure up-to-date, reliable source documents for product registrations are stored, linked, scanned and uploaded into the database.
• Coordinate assessment of product changes to capture any impact to existing or in-process product registrations and letters to file.
• Coordinate with and collect specific registration information from R&D, Marketing, QA, Medical and other applicable departments as necessary.
• Support product (new & change management) registrations in assigned regions; monitor and track progress. Track global registration status for project teams and new products.
• Respond and track the additional information requests (AIRs/ RIM Tasks) submitted by International Regulatory partners.
• Conduct surveys as needed with RoW RA partners to understand regulatory requirements and any other questions needed by the RA team and provide a summary to key stakeholders.
• Provides Monthly registration reports and Quarterly reports as required.
• Provides coordination to obtain regulatory certificates from the FDA or BU partner (CFG, NCR, FSC, CoE, CoO, Chemical composition, etc.) and provide support for notarization, apostille or legalization of the certificates mentioned above.
• Provides RIM and ACR support as needed.
• Additional activities as needed to support RA goals and performs other related duties and assignments as required.

Minimum Qualifications:
Education:
• A minimum of a Bachelor's Degree is required, preferably in the biological sciences, chemistry, or engineering.

Experience:
• Minimum 1 years’ experience in the device/diagnostic, biologic and/or pharmaceutical industry, preferably in the area of regulatory affairs.
• Computer literacy (PC, Microsoft Word/Excel/PowerPoint)
• Demonstrated ability to learn and apply learning to projects.
• Demonstrated ability to handle multiple tasks and to prioritize/ schedule work to meet business needs/deadlines.
• Attention to detail, with emphasis on accuracy and completeness.
• Effective written and oral communication skills.
• Good organizational and planning skills; drives for results.
• Effective analytical/problem-solving skills.
• Good interpersonal skills that involve working well in a team environment and the ability to influence others.
• Ability to exercise reasonably independent judgment and discretion within a defined range of policies and practices.
• Ability to identify areas of concern in moderately complex projects and manage change.

Alex Roy
MillenniumSoft, Inc
8301 Arlington Blvd, Suite # 504
Fairfax, VA 22031
Fax: 703-991-4551
Phone: 703 459 9282 X 105

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