Regulatory Affairs Lead, MedTech Submissions (FDA & Intl)

Becton, Dickinson and Company; San Diego (CA); On-site; USD 130,000 - 207,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Parental leave

Education assistance

Wellness resources

Commuter benefits

Job summary

BD in San Diego is seeking an experienced Regulatory Affairs professional to prepare and execute regulatory submissions for medical devices across US, EU, and other international markets. You will collaborate with R&D, Quality, and Manufacturing to ensure compliance throughout the product lifecycle.

The role emphasizes risk-based decision making, verification and validation, usability, and software considerations to support filings including 510(k), PMA, and IDE.

Qualifications

• Bachelor’s degree in regulatory science, biomedical, pharmaceutical or related field.
• Minimum 5 years of Regulatory Affairs experience in medical devices (FDA Class II/III).
• Experience preparing regulatory submissions (PMA, 510(k), IDE) to FDA and others.

Responsibilities

• Coordinate, prepare, and follow up with FDA Premarket Notification submissions (510(k)).
• Act as liaison with FDA regarding product clearance and changes.
• Prepare internal Justifications for changes not requiring 510(k).
• Prepare technical files/dossiers for international registrations with input from R&D, QA, and Manufacturing.
• Review labeling, advertising and materials for regulatory compliance.
• Represent regulatory affairs in product lifecycle teams and design projects.
• Support international registrations for product changes/new launches.

Skills

Regulatory affairs

FDA 510(k) submissions

Cross-functional collaboration

Risk-based decision making

Education

Bachelor’s degree in Regulatory Science or related field

Job description

BD in San Diego is seeking an experienced Regulatory Affairs professional to prepare and execute regulatory submissions for medical devices across US, EU, and other international markets. You will collaborate with R&D, Quality, and Manufacturing to ensure compliance throughout the product lifecycle.

The role emphasizes risk-based decision making, verification and validation, usability, and software considerations to support filings including 510(k), PMA, and IDE.