Regulatory Strategy Lead – 510(k)/EU MDR (Remote)

Planet Pharma; Jacksonville (FL); On-site; USD 104,000 - 125,000; Full time

Job summary

Planet Pharma in Jacksonville, FL seeks an experienced regulatory professional to manage 510(k) and EU MDR submissions with a strong ownership mindset. The role emphasizes cross-functional coordination and effective interaction with regulatory authorities.

Requirements include a Bachelor’s degree in a scientific discipline and 5–8 years in medical device regulation. This is a full-time role; on-site preferred with potential remote consideration based on experience.

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent.
• 5–8 years of regulatory experience in medical devices.
• Experience with 510(k) and EU MDR submissions and strategy.
• Knowledge of IEC 60601 regulatory requirements.

Responsibilities

• Directs or coordinates document packages for regulatory submissions from all areas of the company.
• Leads or compiles materials required in submissions, license renewals and annual registrations.
• Recommends changes for labeling, manufacturing, and clinical protocol for regulatory compliance.
• Monitors and improves tracking/control systems and interfaces with regulatory agencies as needed.
• Recommends strategies for earliest possible approvals of clinical trial applications.

Skills

Regulatory submissions

IEC 60601 experience

Cross-functional communication

Ownership

Education

Bachelor's degree in a scientific discipline

Job description

Planet Pharma in Jacksonville, FL seeks an experienced regulatory professional to manage 510(k) and EU MDR submissions with a strong ownership mindset. The role emphasizes cross-functional coordination and effective interaction with regulatory authorities.

Requirements include a Bachelor’s degree in a scientific discipline and 5–8 years in medical device regulation. This is a full-time role; on-site preferred with potential remote consideration based on experience.