Sr. Regulatory Affairs Specialist

System One; Mountain View (CA); Hybrid; USD 76,000 - 83,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision coverage

401(k) plan

Job summary

System One is seeking a Sr. Regulatory Affairs Specialist in Sunnyvale, CA. The role requires a BS degree and at least 8 years of Regulatory Affairs experience in medical devices. You will lead regulatory plans, prepare FDA 510(k) submissions, and guide product teams on US, Canada, and EU pathways.

You will collaborate with international teams to support global submissions and drive cross-functional alignment, ensuring timely approvals and compliant labeling and risk management.

Qualifications

• Minimum of 8 years Regulatory Affairs experience in a medical device company.
• Strong knowledge of US Medical Device regulations, Health Canada guidance, and EU MDR.
• Experience with design controls, risk management, V&V, and product labeling.

Responsibilities

• Develop regulatory plans and identify applicable standards and guidance documents.
• Prepare and maintain regulatory submissions including FDA 510(k) and Health Canada submissions.
• Provide regulatory guidance to product teams and coordinate with international counterparts.
• Lead regulatory documentation and author responses with minimal supervision.
• Assess regulatory impact on design, materials, labeling, packaging, and facilities.

Skills

Regulatory affairs

US FDA 510(k)

Health Canada guidance

EU MDR

Design controls

Risk management

Regulatory submissions

Communication skills

Education

BS in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Pharmacy or equivalent

Job description

Job Title: Sr. Regulatory Affairs Specialist
Location: Sunnyvale, CA, United States
Type: Contract
Compensation: $55.00 - $60.00
Work Model: Hybrid

Overview

Established Medical Device company is looking to hire a Sr. Regulatory Affairs Specialist to join their growing team! Must bring a BS Degree and a minimum of 8 years of Regulatory Affairs experience.

Responsibilities

• Develop regulatory plans, review design input/output documentation, and identify applicable standards and guidance documents.
• Perform regulatory assessments to determine the impact of design/process changes.
• Prepare and maintain regulatory submissions, including U.S. FDA 510(k) premarket notifications, Letters to File, pre-submissions, and Health Canada submissions.
• Provide regulatory guidance to product teams, develop strategies for the U.S. and Canadian markets, and influence global regulatory strategies.
• Coordinate with technical experts to provide additional data requested by regulatory agencies and respond to facilitate approvals.
• Assess regulatory impact on design, materials, labeling, packaging, manufacturing processes, and facilities.
• Collaborate with international counterparts to support global regulatory submissions, approvals, and rollout implementation.
• Lead regulatory documentation and author responses with minimal supervision.
• Advise on risk-based guidance to projects while ensuring cross-functional alignment.

Requirements

• Minimum of 8 years of regulatory affairs experience in a medical device company, with a strong understanding of US Medical Device regulations, Health Canada guidance, and EU MDR.
• Knowledge of product lifecycle management, design controls, risk management, verification and validation, and product labeling.
• Ability to work efficiently in a fast-paced environment, managing multiple projects.
• Strong verbal and written communication skills, with the ability to translate technical documentation into effective regulatory submissions.
• Team-oriented, proactive, and capable of negotiating and influencing professionally.
• B.S. or higher in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Pharmacy, or equivalent.
• RAPS RAC certification is a plus.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.