Regulatory Affairs Manager - Neuromodulation Devices

Lumira Search; United States; On-site; USD 120,000 - 160,000; Full time

Job summary

Lumira Search partners with a neuromodulation medical device start-up to recruit a Regulatory Affairs Manager based in the US (California ideal). This role supports regulatory strategy and execution for implantable devices.

You will work with Quality, R&D, Clinical, and Engineering teams to drive submissions, maintain DHF, and ensure compliance across US and international markets. A strong background in FDA pathways and experience with Class II/III devices is required.

Qualifications

• Regulatory affairs experience within medical devices, ideally neuromodulation.
• Minimum 5 years of Regulatory Affairs experience within the Neuro medical device industry.
• Strong knowledge of FDA pathways (510(k), IDE) and submissions.
• Experience with implantable Class II/III medical devices.
• Familiarity with ISO 14971 and design controls.

Responsibilities

• Support regulatory strategy and execution for invasive or non-invasive neuromodulation devices.
• Prepare and maintain regulatory submissions including FDA 510(k), IDE, and other filings.
• Engage with FDA for pre-submissions and regulatory meetings.
• Contribute regulatory input across product lifecycle from development to commercialization.
• Review DHF, risk management files, and product specifications.
• Collaborate with Engineering, Quality, Clinical, and Product teams.
• Support global regulatory activities US and international.
• Monitor changing regulations and advise on compliance strategies.
• Assist with regulatory intelligence and competitive landscape assessments.

Skills

Regulatory affairs

Medical devices

FDA regulatory pathways

Cross-functional teamwork

Regulatory strategy

Education

Bachelor's degree in Engineering/Life Sciences

Tools

DHF documentation

Regulatory submissions

Job description

Lumira Search partners with a neuromodulation medical device start-up to recruit a Regulatory Affairs Manager based in the US (California ideal). This role supports regulatory strategy and execution for implantable devices.

You will work with Quality, R&D, Clinical, and Engineering teams to drive submissions, maintain DHF, and ensure compliance across US and international markets. A strong background in FDA pathways and experience with Class II/III devices is required.