Principal Regulatory Affairs Specialist

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

Overview

Join a pioneering MedTech company that's transforming cardiac care with innovative solutions. The client seeks a Principal Regulatory Affairs Specialist to lead complex regulatory strategies and submissions for Class III implantable devices and software-driven technologies.

Responsibilities

• Author and manage Original PMA submissions and PMA supplements.
• Drive regulatory strategy across the full product lifecycle (Premarket & Post-market).
• Ensure compliance for Class III medical devices, including software-embedded and SaMD products.
• Mentor and train junior regulatory professionals, fostering team growth and expertise.
• Collaborate cross-functionally to support global market access and regulatory excellence.

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.
• Experience with software-embedded or SaMD products.
• Demonstrated ability to mentor and develop junior team members.
• Ability to work on-site in a hybrid model (4 days per week).

EOE

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.

To find out more about Real, please visit www.realstaffing.com