Regional Regulatory Affairs Lead, US
Hybrid (New York)$191.3k - $233.8kFull-timePosted 4mo ago
About the role
Regulatory leader to build and manage the US regulatory affairs function for a medical device company, establishing strategy, processes, and relationships with the FDA, while holding US Agent, Initial Importer, and Medical Device Distributor roles.
Responsibilities
- Set up the US RA function: core processes, SOPs, and a live, in-region quality management system, working closely with the Quality team.
- Manage our relationship with FDA, including device submissions, and guide the implementation of the regulatory pathway for the US device portfolio.
- Build a scalable, state-by-state expansion process and be the voice of the US market in Neko's regulatory planning.
- Hold the US Agent, Initial Importer, and Medical Device Distributor roles, and manage post-market regulatory activity for the region.
- Help shape both the US and global RA strategy and define what the future US team looks like.
Qualifications
- 8+ years in medical device regulatory affairs, with at least 5 focused on FDA-regulated devices.
- A track record as the accountable lead on US clearances or approvals: 510(k), De Novo, or PMA.
- Direct FDA engagement: you've planned and led pre-submission and submission meetings.
- Eligibility and willingness to hold the US Agent, Initial Importer, and Medical Device Distributor roles.
- Experience building processes, SOPs, or teams in a scale-up or greenfield setting, not just working within an established one.
- Experience supporting clinical expansion into new markets or sites.
- A solid grasp of the operations behind that expansion — from in-region setup to scaling day-to-day delivery.
- Hands-on experience using AI for regulatory and market intelligence, documentation preparation, and workflow automation - with the judgement to distinguish what to automate from what requires expert oversight.
- A degree in a relevant field.
Skills
Required:Regulatory strategyFDA submissionsUS Agent / Initial Importer / Medical Device Distributor rolesProcess & team building in scale-up/greenfield
Benefits
- base salary, equity, and full benefits
Last updated Oct 23, 2026. Interested? Apply on the company site.
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