Sr. Regulatory Affairs Specialist

ProKatchers LLC; Santa Clara (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

ProKatchers LLC in Santa Clara, CA seeks a Senior Regulatory Affairs Specialist to lead regulatory strategies for medical devices and pharmaceuticals across international markets. The role requires deep expertise in global regulatory requirements and quality systems, with a track record of managing complex compliance projects in regulated industries.

You will drive audit readiness, change control, regulatory documentation, and KPI dashboards, collaborating with Regulatory Affairs, Quality,

Qualifications

• 5–7 years of experience in medical devices, pharmaceuticals, biotechnology, or other regulated industries.
• Strong knowledge of global regulatory requirements, international compliance frameworks, and quality systems.
• Experience assessing emerging regulations, performing gap assessments, and implementing regulatory changes across international markets.
• Strong project management and cross-functional coordination with Regulatory Affairs, Quality, Labeling, Legal, and Supply Chain teams.
• Experience in audit readiness, compliance risk management, change control, regulatory documentation, and KPI dashboards.

Responsibilities

• Lead regulatory submissions and maintain global registrations.
• Assess new regulations and perform gap assessments.
• Coordinate with Regulatory Affairs, Quality, Labeling, Legal, and Supply Chain teams.
• Maintain audit readiness and compliance risk management.
• Prepare regulatory documentation and KPI dashboards.

Skills

Regulatory Affairs

Medical Device

Education

Bachelor

Job description

Job Title : Sr. Regulatory Affairs Specialist

Duration : 12 Months

Education : Bachelor

Specific Skills :

Regulatory Affairs AND Medical Device

Job Description :

• Seeking a Senior Regulatory Affairs Specialist with 5–7 years of experience in medical devices, pharmaceuticals, biotechnology, or other regulated industries.
• Must have strong knowledge of global regulatory requirements, international compliance frameworks, and quality systems.
• Responsible for assessing emerging regulations, conducting gap assessments, and implementing regulatory changes across international markets.
• Requires strong project management and cross-functional coordination with Regulatory Affairs, Quality, Labeling, Legal, and Supply Chain teams.
• Must have experience in audit readiness, compliance risk management, change control, regulatory documentation, and KPI dashboards.