Regulatory Affairs Associate

Lensa; Santa Clara (CA); On-site; USD 90,000 - 96,000; Full time

Job summary

A leading career site is assisting in the recruitment of a Regulatory Affairs Associate for a client in Santa Clara, CA. This entry-level role focuses on ensuring compliance with international regulations and improving quality systems. Candidates will be responsible for tracking regulatory changes and implementation, requiring strong analytical skills and attention to detail.

Qualifications

• Entry-level position in regulatory affairs.
• Requires monitoring and implementation of regulations.
• Focus on maintaining quality system procedures.

Responsibilities

• Monitor changing regulations and translate requirements.
• Drive implementation of international regulatory requirements.
• Fulfill international submission deliverables for product registration.

Skills

Monitoring regulations

Implementation of regulatory requirements

Quality system process improvement

Job description

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Lensa is the leading career site for job seekers at every stage of their career. Our client, Manpower Group Inc., is seeking professionals in Santa Clara, CA. Apply via Lensa today!

Title : Regulatory Affairs Associate

Location : Santa Clara, California

Duration : 6 Month

100% Onsite

Pay Range: 45/hr W2

Responsibilities

• 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 guidance are met,
• Fulfilling international submission deliverables for product registration renewals and for regulatory emerging issues where multiple medical devices require submission, including maintaining tracker of Declarations of Conformity, confirming against local requirements, and driving to issuance.
• 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 and Participating in RA projects.
  
  

ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

• Industries

  IT Services and IT Consulting

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