# Regulatory Specialist : FDA & Global Compliance - Full Time Hybrid

**Company:** [RetinAI Medical](http://jobs.workable.com/companies/cG783xuCBPwG4S5xWvdzvG.md)
**Location:** Remote
**Workplace:** remote
**Employment type:** Full-time
**Department:** Quality and Regulatory Affairs

[Apply for this job](http://jobs.workable.com/view/e1ec7b1e-60d6-484a-bb17-b2e2c860666b)

## Description

We are looking for a Regulatory Specialist:  FDA & Global Compliance to join our team. This role is pivotal in ensuring regulatory compliance of our Software as a Medical Device (SaMD) products across the US and international markets. The position will focus on FDA regulatory activities, including pre-submissions, 510(k), and DeNovo pathways, while also supporting MDR compliance, QMS processes, and global regulatory strategy.

As part of a growing team, this role offers the opportunity to shape regulatory processes, support clinical and product development, and contribute to the company’s expansion into new markets and certifications.

### Key Responsibilities

FDA Regulatory Compliance

-   Prepare and manage FDA submissions including 510(k), DeNovo, Pre-Submission, and Breakthrough Designation
-   Ensure completeness and compliance of all regulatory documentation
-   Coordinate cross-functional inputs for submissions (clinical, risk, usability, technical documentation)

US Compliance & Reimbursement

-   Support development of US reimbursement strategy (CPT codes, payer engagement)
-   Ensure compliance with FDA, SOC2, and future MDSAP requirements
-   Support SOC2 certification processes and data privacy/security compliance

MDR & International Regulatory

-   Support MDR compliance and technical documentation
-   Ensure alignment with ISO 13485 and ISO 14971 requirements
-   Contribute to global regulatory strategy and future certifications (e.g. MDSAP Canada)

Quality Management System (QMS)

-   Maintain and improve QMS processes related to regulatory compliance
-   Review promotional and training materials for regulatory compliance
-   Support design control, risk management, and documentation updates

Audits & Compliance

-   Support internal, external, and notified body audits
-   Perform risk assessments and usability evaluations
-   Support supplier/distributor evaluation and compliance processes

Cross-functional Collaboration

-   Work with clinical teams on retrospective and prospective studies
-   Collaborate with R&D, product, and legal teams on regulatory requirements
-   Support regulatory input in product development and change management

Continuous Improvement

-   Improve regulatory and quality processes
-   Support integration of compliance into development lifecycle
-   Monitor regulatory landscape (FDA, MDR, global)

## Requirements

-   Bachelor’s or Master’s degree in Life Sciences, Engineering, Regulatory Affairs, or related field
-   7+ years of experience in regulatory affairs (FDA focus)
-   Experience with:

-   FDA submissions (510(k), DeNovo, Pre-Sub)
-   SaMD (Software as a Medical Device)
-   ISO 13485 and ISO 14971
-   MDR and EU regulatory framework

-   Knowledge of clinical studies (retrospective & prospective)
-   Understanding of US reimbursement landscape is a plus
-   Experience with SOC2 / MDSAP is a plus
-   Strong analytical and problem-solving abilities
-   High attention to detail
-   Ability to manage multiple projects simultaneously
-   Strong communication and stakeholder management skills
-   Ability to work cross-functionally in an international environment
-   Excellent verbal and written English communication skills

## Benefits

-   A chance to be part of an exceptional team driving innovation in healthcare.
-   A competitive salary in a supportive work environment that fosters work-life balance.
-   Opportunities for professional growth and development in an international setting.
-   A culture of collaboration and inclusion, which is fundamental to our ethos.
-   Occasional travel to our HQ in Switzerland, immersing you in our core operations and company culture.