This is Bhanu from Intellectt INC; we’ve got an important role Regulatory Affairs Compliance Specialist - Santa Clara, CA with one of our prestigious clients. Interested candidates can please send your updated resume at bhanu@intellectt.com
Role: Regulatory Affairs Compliance Specialist
Location: Santa Clara, California - 95054-2807
Duration: 6 Months
Job Description
This role will provide compliance support to the Regulatory Affairs organization by –
Driving preparation of KPI dashboards and maintaining a pulse on formal RA management review and internal metrics.
Managing strategic program for RA audit preparedness including anticipatory identification of risks, mitigation of risks identified during the audit process, and preventive actions for risks.
Supporting quality system integration for acquisitions and new product introductions.
Identifying and implementing system and/or systemic processes.
Supporting tracking and maintenance of regulatory post-approval commitments.
Driving quality system process improvement initiatives
Initiatives Include But Are Not Limited To
Establishing audit support for integration products,
Improving and Maintaining the quality system procedures (e.g., change management)
Liaising with cross-functional partners and international affiliates to meet audit compliance needs and driving to implementation/resolution.
Participating in audit backrooms, and
Participating in RA projects.
Role has a potential for investigating nonconformances (CAPAs) and implementing mitigations. Exposure to Medical Device US and CE regulations, Quality Systems, a Quality role, or a Compliance role is a plus.
List Of Tasks
RA Change Requests Tracking and Closure
Change management
Develop and implement an “auditing plan” for critical RA tasks (e.g., mock audits for Technical Files/Technical Documentations, Impact Assessments, Archival) as part of audit risk mitigation activities.