Senior Regulatory Lead: Class III MedTech & SaMD

Real; Sunnyvale (CA); Hybrid; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Paid leave

Job summary

A pioneering MedTech company in California is looking for a Principal Regulatory Affairs Specialist to spearhead complex regulatory strategies for Class III devices. This role involves authoring PMA submissions, ensuring compliance for medical devices, and mentoring junior staff. Strong background in regulatory affairs and experience with software-embedded products are essential. The position offers a hybrid work culture, allowing flexibility while contributing to transformative cardiac care.

Qualifications

• 7+ years of experience in Regulatory Affairs within the medical device industry.
• Proven experience authoring Original PMA and PMA supplements.
• Strong background in full-cycle Class III device regulatory processes.

Responsibilities

• Author and manage Original PMA submissions and PMA supplements.
• Drive regulatory strategy across the full product lifecycle.
• Ensure compliance for Class III medical devices.

Skills

Regulatory Affairs expertise

Mentoring junior staff

Collaboration skills

Job description

A pioneering MedTech company in California is looking for a Principal Regulatory Affairs Specialist to spearhead complex regulatory strategies for Class III devices. This role involves authoring PMA submissions, ensuring compliance for medical devices, and mentoring junior staff. Strong background in regulatory affairs and experience with software-embedded products are essential. The position offers a hybrid work culture, allowing flexibility while contributing to transformative cardiac care.