Title: Regulatory Regulatory Affairs/Operations Specialist

Location: Santa Clara, CA- 95054

Duration: 12 Months

Description / Summary:

This role will provide compliance support to the Regulatory Affairs organization by –

a. Driving preparation of KPI dashboards and maintaining a pulse on formal

RA management review and internal metrics.

b. 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.

c. Supporting quality system integration for acquisitions and new product

introductions.

d. Identifying and implementing system and/or systemic processes.

e. Supporting tracking and maintenance of regulatory post-approval

commitments.

f. Driving quality system process improvement initiatives

Initiatives include but are not limited to:

1. Establishing audit support for integration products, 2. Improving and Maintaining the quality system procedures (e.g., change

management)

3. Liaising with cross-functional partners and international affiliates to meet audit compliance needs and driving to implementation/resolution.

4. Participating in audit backrooms, and 5. 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.

• CAPAs/Auding Finding management.

• Post-Approval Commitments management

• Support QMS audits from an RA perspective

• Support QMS Integration tasks

• Management Review Metrics results

Skills:

• Independent

• Troubleshooting

• Critical thinker

• Ability to drive a problem through resolution and implement mitigations.

• Ability to handle multiple streams simultaneously.