Regulatory Compliance Specialist Job

SENIOR REGULATORY COMPLIANCE SPECIALIST needed for a CONTRACT opportunity with Yoh's client located in Sunnyvale, CA.

TOP SKILLS SHOULD YOU POSSESS:

- Medical Device
- Regulatory Compliance
- CQA/CQE

WHAT YOU'LL BE DOING:

- Ensure overall QMS system compliance with applicable regulatory and statutory requirements.
- Review and approve ECO's for Regulatory Compliance as needed.
- Review risk management and FMEA documents for consistency and compliance with regulatory and procedural requirements.
- Responsible for assisting in the investigating complaints/issues for potential reporting under the FDA Medical Device Reporting regulations, preparing draft PIR summaries and reports for presentation to the PIR forum for review and maintaining documentation in accordance with department policies, procedures and work instructions.
- Establish and prepare Quality Review Board metrics for the Regulatory Compliance group.
- Compile, monitor, and report on trending of pertinent RA/QA related metrics, as required.
- Identify areas of opportunity and support continual improvement of the Quality Management System.
- Monitors and audits adherence to corporate policies and investigate any violations, including
- coordinating investigations, audits, conducting interviews, and preparing reports.
- Control access to, and maintain the organization of, the Qualityable to work effectively and professionally with external people including Customers and government officials.
- Demonstrated ability to effectively collaborate and partner with all levels of management in corporate and division level sites while maintaining an appropriate assertive style is critical.
- Certified Quality Auditor/ISO lead Auditor Certified.

WHAT'S IN IT FOR YOU?

Sr. Regulatory Compliance Specialist will implement and execute to an efficient, effective and sustainable processes to ensure on-going compliance with domestic and international regulations and standards. This includes evaluating the relevance to all facilities and products and implementing efficient and effective processes to ensure adherence to applicable regulations and standards.

WHAT ARE YOU WAITING FOR? APPLY NOW!

RECRUITER: Will Thompson

Yoh, a DayTHIS ADDRESS IS EXCLUSIVELY FOR INDIVIDUALS WITH DISABILITIES REQUESTING APPLICATION ASSISTANCE.

J2W: CLINICAL

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