Regulatory Affairs Device Specialist - Global Submissions

Synectics Inc.; Irvine (CA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Healthcare Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Job summary

Synectics Inc. in Irvine, CA is seeking a Regulatory Affairs Device professional to partner with internal and external teams to deliver patient-ready products. The role focuses on crafting regulatory strategies and submissions for device approvals under limited supervision.

You will manage INDs/CTAs, liaise with RA, R&D, and Operations, and supervise responses to health authorities. This position requires experience with EU Class IIb devices and knowledge of EU MDR 2017/745, with a track record

Qualifications

• Experience supporting new device submissions and variations internationally.
• 3–5 years of direct device regulatory experience.
• Recent experience with Class IIb (EU) medical devices and EU MDR 2017/745.

Responsibilities

• Develop regulatory strategy enabling first-pass approvals under limited supervision.
• Manage content strategy for regulatory submissions (INDs/CTAs, new market apps, variations).
• Collaborate with RA, Operations and R&D on product development and lifecycle management.
• File regulatory applications and manage government interactions for approved products.
• Review engineering study and validation reports; approve manufacturing changes for EU Class IIb devices.

Skills

Regulatory submissions

EU MDR

Class IIb

Global submissions

Stakeholder comms

Education

Advanced degree

Job description

Synectics Inc. in Irvine, CA is seeking a Regulatory Affairs Device professional to partner with internal and external teams to deliver patient-ready products. The role focuses on crafting regulatory strategies and submissions for device approvals under limited supervision.

You will manage INDs/CTAs, liaise with RA, R&D, and Operations, and supervise responses to health authorities. This position requires experience with EU Class IIb devices and knowledge of EU MDR 2017/745, with a track record