Regulatory Affairs Manager

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 have partnered with a neuromodulation medical device start-up searching for a Regulatory Affairs Manager based in the US (California based is ideal). Our client is an early-stage company developing a truly ground-breaking solution for the treatment for Chronic Pain and is entering a critical phase of regulatory and clinical development.

This is an exciting opportunity to join a growing organization at a pivotal stage, supporting regulatory strategy and execution for implantable neuromodulation devices designed to improve patient outcomes in chronic pain management.

The successful candidate will play a key role in supporting US regulatory activities, working closely with Quality, R&D, Clinical, and Engineering teams to ensure successful product development and regulatory submissions.

Key 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 regulatory filings.
• Support interactions with the FDA, including pre-submissions and regulatory meetings.
• Provide regulatory input throughout the product lifecycle, from early development through commercialization.
• Review and contribute to technical documentation, design history files (DHF), risk management files, and product specifications.
• Work cross-functionally with Engineering, Quality, Clinical, and Product teams to ensure regulatory requirements are met.
• Support global regulatory activities across US and international markets.
• Monitor evolving regulatory requirements and provide guidance on compliance strategies.
• Assist with regulatory intelligence and competitive landscape assessments.

Desired Candidate Profile:

• Regulatory Affairs experience within medical devices, ideally focused on neuromodulation
• Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or a related scientific or technical discipline
• Minimum of 5 years of Regulatory Affairs experience within the Neuro medical device industry
• Strong understanding of FDA regulatory pathways, including 510(k), IDE, and associated submission requirements.
• Experience supporting implantable Class II/III medical devices.
• Knowledge of design controls, risk management (ISO 14971), and medical device quality systems.
• Experience working with cross-functional product development teams.
• Ability to operate effectively in a fast-paced start-up or scale-up environment.
• Strong communication skills with the ability to manage internal stakeholders and external regulatory interactions.
• Experience within pain management, neurostimulation, SCS, DBS, PNS, or related neuromodulation markets preferred.

Please note: I anticipate a high volume of applicants and I’m unable to respond to all. If you do not meet the above criteria and haven’t heard from me within 14 days of applying, please assume your application has been unsuccessful.