Regulatory Affairs Associate (Submission / Product Registration) job vacancy in Rangam Consultants Inc. – Jobs in California

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Job Details
Company Name : Rangam Consultants Inc.
Company Location : Santa Clara, CA 95051
Job Position : Regulatory Affairs Associate (Submission / Product Registration)
Job Category : Jobs in California

Job Description :
Updates From Manager:
a. Monitoring changing regulations (emerging regulatory issues, trends) in rest of the world geographies and translating regulatory requirements into the quality systemb. Driving implementation of new international regulatory requirements, ensuring procedures are current and regulatory requirements and guidances are met,c. Fulfilling international submission deliverables for product registration renewals and for regulatory emerging issues where multiple medical devices require submission, andd. Driving quality system process improvement initiatives.
Initiatives include but are not limited to:
1. Establishing emerging issues in our quality system,2. Maintaining the quality system procedures (e.g. change management),3. Liaising with cross-functional partners, distribution centers, and international affiliates to obtain/align on international regulatory requirements,4. Troubleshooting with regulatory affiliates, and5. Participating in RA projects. Role has a potential for investigating nonconformances (CAPAs) and implementing mitigations. Exposure to Quality Systems, a Quality role, or a Compliance role is a plus.
After onsite training (a few weeks) will be open to a hybrid. This is more International Submission – compliance and quality systems work.

This role will provide support to the Regulatory Affairs organization by – a. Monitoring changing regulations (emerging regulatory issues, trends) in rest of the world geographies and translating regulatory requirements into the quality system,
Driving implementation of new international regulatory requirements, ensuring procedures are current and regulatory requirements and guidances are met,
Fulfilling international submission deliverables for product registration renewals and for regulatory emerging issues where multiple medical devices require submission,
Driving quality system process improvement initiatives.

Initiatives include but are not limited to:

Establishing emerging issues in our quality system,
Maintaining the quality system procedures (e.g. change management),
Liaising with cross-functional partners, distribution centers, and international affiliates to obtain/align on international regulatory requirements,
Troubleshooting with regulatory affiliates,
Participating in RA projects.
Role has a potential for investigating nonconformances (CAPAs) and implementing mitigations.
Exposure to Quality Systems, a Quality role, or a Compliance role is a plus.

Job Type: Contract
Salary: $26.67 – $42.00 per hour
Schedule:

8 hour shift
Monday to Friday

Ability to commute/relocate:

Santa Clara, CA 95051: Reliably commute or planning to relocate before starting work (Required)

Education:

Bachelor’s (Preferred)

Experience:

international submission: 2 years (Preferred)
product registration: 2 years (Preferred)
medical device industry: 2 years (Preferred)
Quality Systems & Compliance: 2 years (Preferred)
CAPA: 2 years (Preferred)
Regulatory affairs: 2 years (Preferred)

Work Location: One location