Senior Regulatory Affairs Specialist

The Fountain Group; Santa Clara (CA); On-site; USD 60,000 - 86,000; Full time

Job summary

The Fountain Group seeks a Senior Regulatory Affairs Specialist to support the implementation of emerging global regulatory requirements across medical device franchises and international markets. Responsibilities include coordinating regulatory changes, tracking compliance, and updating quality systems and labeling processes, while ensuring ongoing market access.

The role requires 5–7 years in regulatory affairs or related fields, with experience in QMS and regulatory reporting.

Qualifications

• 5–7 years of experience in Regulatory Affairs, Regulatory Compliance, Regulatory Operations, or Quality Systems within a medical device or other regulated industry.
• Global regulatory requirements and international compliance frameworks.
• Regulatory change assessment and implementation.
• Regulatory compliance gap assessments and remediation planning.
• Quality Management Systems (QMS) and procedural updates.
• Regulatory change control and change order management.
• Audit readiness, inspection support, and remediation tracking.
• Regulatory governance, compliance tracking, and implementation oversight.
• KPI dashboards, compliance trackers, and management review metrics.
• Regulatory project management across multiple international markets.

Responsibilities

• Support the implementation of emerging global regulatory requirements across medical device franchises and international markets.
• Coordinate regulatory implementation across Regulatory Affairs, Quality, Labeling, Supply Chain, Legal, and international affiliate teams.
• Maintain regulatory compliance KPIs and management review dashboards.

Skills

Regulatory knowledge

Audit readiness

Regulatory change control

QMS awareness

Cross-functional collaboration

Regulatory reporting

Education

Bachelor's degree in Regulatory Affairs or Life Sciences

Job description

Job Title: Senior Regulatory Affairs Specialist
Location:Santa Clara, CA
Pay Rate: $53/hr.
Duration: 1 Year

Job Description

Seeking a Senior Regulatory Affairs Specialist to support the implementation of emerging global regulatory requirements across medical device franchises and international markets. Responsibilities include assessing regulatory changes, conducting compliance gap assessments, coordinating implementation plans, updating quality systems and labeling processes, managing regulatory change orders, tracking audit remediation activities, and maintaining compliance KPIs and management review dashboards.

The specialist will coordinate regulatory implementation across Regulatory Affairs, Quality, Labeling, Supply Chain, Legal, and international affiliate teams to maintain regulatory compliance and support continued market access.

Education

• Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field preferred.

Required Skills

• 5–7 years of experience in Regulatory Affairs, Regulatory Compliance, Regulatory Operations, or Quality Systems within a medical device or other regulated industry.

• Global regulatory requirements and international compliance frameworks.

• Regulatory change assessment and implementation.

• Regulatory compliance gap assessments and remediation planning.

• Quality Management Systems (QMS) and procedural updates.

• Regulatory change control and change order management.

• Audit readiness, inspection support, and remediation tracking.

• Regulatory governance, compliance tracking, and implementation oversight.

• KPI dashboards, compliance trackers, and management review metrics.

• Regulatory project management across multiple international markets.

Preferred Skills

• Medical device regulatory compliance experience.

• Experience coordinating pan-franchise regulatory implementation initiatives.

• Post-approval regulatory commitments management.

• Regulatory labeling process updates.

• Emerging regulatory issues assessment and implementation.

• Experience with compliance governance reporting and process improvement initiatives.
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