Regulatory Affairs Device Associate II — EU Class IIb Submissions

Planet Pharma; Irvine (CA); On-site; USD 45,000 - 59,000; Full time

Job summary

Planet Pharma is seeking an Regulatory Affairs professional for a device-focused role based in Irvine, CA. The position collaborates with internal and external partners to deliver regulated medical devices to patients, with a focus on EU submissions and global variations.

Responsibilities include strategy development, cross-functional engagement, and timely government filings while ensuring compliance with EU MDR 2017/745.

Qualifications

• Experience supporting new device submissions and variations in global regions (non-US).
• Recent experience with Class IIb medical devices and EU submissions/renewals.
• Knowledge of EU MDR 2017/745 and regulatory expectations.
• Proven track record of authoring submissions and obtaining approvals for Class IIb devices.
• Ability to leverage extensive experience and judgment to influence cross-functional teams.

Responsibilities

• Prepares device regulatory strategies enabling first pass approvals with limited supervision.
• Manages content strategy for regulatory submissions (INDs/CTAs, market applications, variations).
• Represents RA Device on product development and life-cycle teams to advise peers.
• Filing of required applications and handling government interactions for regulated products.
• Review/approval of engineering study protocols and manufacturing changes for Class IIb devices.

Skills

Regulatory affairs

Medical devices

EU MDR

Submission strategy

Education

Advanced degree

Job description

Planet Pharma is seeking an Regulatory Affairs professional for a device-focused role based in Irvine, CA. The position collaborates with internal and external partners to deliver regulated medical devices to patients, with a focus on EU submissions and global variations.

Responsibilities include strategy development, cross-functional engagement, and timely government filings while ensuring compliance with EU MDR 2017/745.