Job Title :Regulatory Affairs Operations Specialist
Location: Santa Clara CA
Duration: 12 Months 

We are seeking a detai loriented and proactive Regulatory Affairs Operations Specialist to support our Regulatory Affairs team.
This role plays a key part in ensuring compliance with international regulatory
requirements, maintaining highquality documentation standards, and supporting crossfunctional initiatives across global markets.
 Candidates should have below criteria
• 5+ years of experience in Regulatory Affairs
• Hands-on experience with regulatory labeling, specifically addendum labeling, supplemental labeling, and/or execution of labeling changes
• Demonstrated familiarity with regulated medical device environments and quality systems.
Given the nature of the work, it’s important that candidates are seasoned and can operate with minimal ramp-up.

Summary of Responsibilities:

• The Regulatory Affairs Operations specialist will provide support to the Regulatory Affairs organization by –
• Drive implementation of new international regulatory requirements, ensuring procedures are current and compliant with applicable guidance and requirements.
•  Lead quality system process improvement initiatives
•  Prepare KPI dashboards and maintaining a pulse on internal Regulatory Affairs (RA) metrics.
•  Coordinate panfranchise requests for multiple products, including scheduling and facilitating meetings with international stakeholders
•  Submit and track addendum labeling requests.
•  Liaise with crossfunctional partners, distribution centers, and international affiliates to align on regulatory requirements, documentation, addendum labeling, and regulatory letters.

Key tasks and Initiatives:

• Initiatives include but are not limited to:
•  Prepare and submit certificates to Foreign Governments (CFG) requests via the FDA database.
•  Maintain tracker and review Declarations of conformity (DoC):
•  Ensure adherence to Good Documentation Practices (GDP)
•  Manage translation requests using the Acolad portal
•  Review EU MDR DoC translations for accuracy and consistency
•  Review Regulatory Letters and maintain tracker for Letter of
• Authorization (LoA), Power of Attorney (PoA), tenders, controlled substances and evidence of conformance letters.
•  Maintain uptodate trackers, SharePoint sites, and documentation repositories
•  Support change management activities, including change orders (CO) for DoC templates and quality system procedures
•  Establishing emerging issues within the quality system,
•  Participate in RA projects and continuous improvement initiatives
•  Troubleshoot regulatory issues in collaboration with international regulatory affiliates
• This 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.

Skills:

•  Independent
•  Troubleshooting
•  Critical thinker
•  Ability to drive a problem through resolution and implement mitigations
•  Ability to handle multiple streams simultaneously

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 39.00/daily.