Global Regulatory Affairs Lead - Medical Devices

BD; San Diego (CA); On-site; USD 130,000 - 190,000; Full time

Benefits offered by this job

Health benefits (medical, dental, &amp

401(k) plan with matching

Paid time off and holidays

Job summary

BD in the United States seeks a Regulatory Affairs professional to lead regulatory submissions for medical devices across the US, Europe, and other markets. You will develop regulatory strategies and manage submissions to ensure lifecycle compliance across V&V, risk management, usability, reprocessing, and software development.

You will collaborate with R&D, Quality, Manufacturing and Marketing to align product development with regulatory requirements and business goals, writing SOPs and

Qualifications

• Bachelor’s degree in regulatory science or related field.
• Minimum 5 years regulatory affairs experience in the medical device industry.
• Experience with FDA submissions (510(k), PMA, IDE) and international regulatory filings.
• Knowledge of V&V, risk management, usability, reprocessing, biocompatibility, and software development.
• Ability to resolve regulatory issues under pressure and articulate regulatory strategy.

Responsibilities

• Coordinate FDA Premarket Notification (510(k)) submissions and liaison with FDA.
• Assess need for 510(k) for device changes; prepare non-filing justifications.
• Prepare technical files/dossiers for international registrations with cross-functional input.
• Review labeling and promotional materials for regulatory compliance.
• Represent RA in product lifecycle and design teams; provide regulatory guidance.

Skills

Regulatory submissions

FDA expertise

Cross-functional collaboration

Risk-based decision making

Regulatory strategy development

Education

Bachelor’s degree in Regulatory Science or related field

Job description

BD in the United States seeks a Regulatory Affairs professional to lead regulatory submissions for medical devices across the US, Europe, and other markets. You will develop regulatory strategies and manage submissions to ensure lifecycle compliance across V&V, risk management, usability, reprocessing, and software development.

You will collaborate with R&D, Quality, Manufacturing and Marketing to align product development with regulatory requirements and business goals, writing SOPs and