Regulatory Affairs Associate II - Medical Devices (EU MDR)

Planet Pharma; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Planet Pharma is seeking a Regulatory Affairs professional to lead device regulatory strategies and submissions. The role collaborates with RA, R&D, and Operations to influence product development and lifecycle management.

Responsibility includes filing regulatory applications and managing authority interactions for products requiring approvals. The candidate will review protocols and manufacturing changes, with a focus on EU MDR 2017/745 requirements and Class IIb device experience across

Qualifications

• Experience building regulatory submissions and responding to health authority questions.
• Experience with Class IIb (EU) medical devices and EU MDR 2017/745 knowledge.
• 3–5 years of direct regulatory affairs experience; advanced degree may be required.
• Experience submitting changes/renewals and authoring submissions outside the US (JAPAC, MEAR, LATAM).
• Strong ability to influence peers and manage cross-functional teams.

Responsibilities

• Prepare device regulatory strategies to enable first-pass approvals under limited supervision.
• Develop and manage content strategies for regulatory submissions (INDs/CTAs, amendments, new market apps).
• Represent RA during product development and lifecycle management discussions to influence teams.
• File necessary regulatory applications and manage government interactions for regulated products.
• Review study protocols/reports and validation protocols/reports for compliance.
• Review and approve manufacturing changes for Class IIb devices (EU).

Skills

Regulatory strategy

Content strategy

Stakeholder management

Negotiation

Regulatory submissions

Documentation review

Manufacturing changes review

Education

Advanced degree

Job description

Planet Pharma is seeking a Regulatory Affairs professional to lead device regulatory strategies and submissions. The role collaborates with RA, R&D, and Operations to influence product development and lifecycle management.

Responsibility includes filing regulatory applications and managing authority interactions for products requiring approvals. The candidate will review protocols and manufacturing changes, with a focus on EU MDR 2017/745 requirements and Class IIb device experience across